Effects of Nutritional Preconditioning on the Malnourished Patient`s Outcomes After Surgery
| Status: | Not yet recruiting |
|---|---|
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 12/5/2018 |
| Start Date: | March 1, 2019 |
| End Date: | December 30, 2020 |
| Contact: | Amir H Fathi, MD |
| Email: | AFathi@fresno.ucsf.edu |
| Phone: | (559) 256-5140 |
Effects of Nutritional Preconditioning on the Nutritional Status of Patients Undergoing Major General Surgeries and Subsequent Operative Outcomes
Malnutrition is a serious problem in patients undergoing major surgeries and has a direct
association with increased morbidity, mortality, length of stay (LOS), increased readmissions
and cost of care. Studies suggest several advantages of supplementation with protein or
specific amino acids in malnourished patients. Dietary leucine or its metabolite β-hydroxy
β-methylbutyrate (HMB) can improve skeletal muscle mass and function by increasing
transcriptional level of protein synthase, while other high protein or amino acids like
Glutamine or Arginine supplements only provide protein-amino acids pool for patients while
body`s preferred fuel during metabolic stress is endogens protein, rather than exogenous
diet.
In this study the investigators seek to achieve two distinct goals:
1. Determine the patients' nutritional status before and after major surgeries by baseline
and subsequent nutritional assessments, according to ASPEN's criteria. In addition, the
investigators were going to use indirect calorimetry to determine the Resting Energy
Expenditure (REE) in different phases of pre- and postoperative periods. The
investigators also propose to compare different serum protein markers and their ratios
in order to correlate them with ASPEN's criteria for nutritional status quantification.
In Summary, three discrete tools including ASPEN's criteria, indirect calorimetry, and
serum biomarkers are going to be used in conjunction with each other to delineate the
patients' nutritional status in various pre- and post-operative periods.
2. Patients undergoing major surgeries were supplemented with high protein with ß-hydroxy
ß-methylbutyrate (HMB) (Ensure, Envile) or HMB only as a control, in order to improve
their nutritional status and improve postoperative outcomes. The investigators looked
for depict meaningful improvements in surgical outcomes by nutritional supplementation
with or without HMB.
association with increased morbidity, mortality, length of stay (LOS), increased readmissions
and cost of care. Studies suggest several advantages of supplementation with protein or
specific amino acids in malnourished patients. Dietary leucine or its metabolite β-hydroxy
β-methylbutyrate (HMB) can improve skeletal muscle mass and function by increasing
transcriptional level of protein synthase, while other high protein or amino acids like
Glutamine or Arginine supplements only provide protein-amino acids pool for patients while
body`s preferred fuel during metabolic stress is endogens protein, rather than exogenous
diet.
In this study the investigators seek to achieve two distinct goals:
1. Determine the patients' nutritional status before and after major surgeries by baseline
and subsequent nutritional assessments, according to ASPEN's criteria. In addition, the
investigators were going to use indirect calorimetry to determine the Resting Energy
Expenditure (REE) in different phases of pre- and postoperative periods. The
investigators also propose to compare different serum protein markers and their ratios
in order to correlate them with ASPEN's criteria for nutritional status quantification.
In Summary, three discrete tools including ASPEN's criteria, indirect calorimetry, and
serum biomarkers are going to be used in conjunction with each other to delineate the
patients' nutritional status in various pre- and post-operative periods.
2. Patients undergoing major surgeries were supplemented with high protein with ß-hydroxy
ß-methylbutyrate (HMB) (Ensure, Envile) or HMB only as a control, in order to improve
their nutritional status and improve postoperative outcomes. The investigators looked
for depict meaningful improvements in surgical outcomes by nutritional supplementation
with or without HMB.
Background and Significance:
The concept of malnutrition and its' effects on the outcomes of surgical patients was first
reported in 1936. A study revealed that malnourished patients going through ulcer surgery had
a 33 percent mortality rate when compared with 3.5 percent in well-nourished individuals.
According to the American Society of Parenteral and Enteral Nutrition (ASPEN) guidelines,
malnutrition is defined as 'an acute, subacute or chronic state of nutrition, in which
varying degrees of overnutrition or undernutrition with or without inflammatory activity have
led to a change in body composition and diminished function'.
Acute malnutrition is present in 25 to 54% of hospitalized patients at admission.
Malnutrition has a direct association with increased morbidity, mortality, length of stay
(LOS), increased readmissions and cost of care. A prospective study of 500 patients,
including 200 surgical patients, demonstrated that patients lost an average of 5.4 percent of
their body weight during their hospital stay. Also, the stress of surgery or trauma creates a
hypermetabolic state with an increased Basal Metabolic Rate (BMR) while raising protein and
energy requirements.
Furthermore, during illness, the metabolic demand, as well as recovery time, are increased.
This situation could increase the risk of malnutrition or shift it from at risk of
malnutrition to mild to moderate or even severe cases, resulting in a further increase in
subsequent recovery time. The aforementioned condition is more evident in major surgical
candidates because of metabolic stress leading to a general lack of desire to eat, malaise,
fatigue and oftentimes depression interrupting normal eating processes and food intake while
disturbing digestion and absorption. This condition results in skeletal muscle loss and usage
of internal amino acids for endogenous glucose production (Gluconeogenesis). With the loss of
skeletal muscle, protein and energy availability is lowered throughout the body. Muscle loss
is also associated with delayed recovery from illness after surgery, slow wound healing and
higher healthcare costs.
Measuring metabolic demand Given the increased caloric demand in a hypermetabolic state, the
patient requires increased energy. Determining the exact amount of energy required has proven
to be a moving target. Indirect calorimetry (IC), which is based on measurements of oxygen
and carbon dioxide production (see attachment), has been shown to be the gold standard for
Resting Energy Expenditure (REE) measurement in critically ill patients. However, this method
is often underutilized due to staff shortage, equipment costs, and lack of knowledge and
interpretation. Instead, predictive equations, such as the Mifflin St. Jeor, are used when
other more precise methods, such as IC, are not available. These predictive equations are
less precise, as they may not account for the increased demand due to the hypermetabolic
state of the patient undergoing major surgeries, whose metabolic demand can increase as much
as 150-200% above the Resting Energy Expenditure (REE). Therefore, the risk of inadequate
energy intake is increased in these patients.
Screening and diagnosis of malnutrition
A number of well-known tools such as the Mini Nutrition Assessment (MNA), Graz Malnutrition
Screening (GMS), Malnutrition Universal Screening Tool (MUST), Malnutrition Screening Tool
(MST) and Subjective Global Assessment (SGA) are available to identify malnutrition. Although
these tools have been validated, they can be limiting as they are self-directed and
malnourished patients rarely receive adequate nutritional assessment and treatment prior to
surgery. Instead, a recent expert consensus suggests that a diagnosis of malnutrition
requires that the patient exhibit two or more of the six Parenteral and Enteral Nutrition`s
(ASPEN) criteria for the diagnosis of malnutrition:
- Insufficient energy intake
- Weight loss
- Loss of muscle mass
- Loss of subcutaneous fat
- Localized or generalized fluid accumulation that may sometimes mask weight loss
- Diminished functional status as measured by hand grip strength Additionally, serum
proteins such as albumin, prealbumin (PAB) and C-Reactive Protein (CRP) have been widely
used by physicians as a marker for nutritional status. They provide a quantitative
measure to indirectly evaluate malnutrition and its severity in patients undergoing
surgery. Because of the overlap of malnutrition with chronic and acute inflammation, it
can be challenging to predict, as well as identify, malnutrition. Acute inflammation
seen in many chronic diseases could lead to hypermetabolism, rendering the patient in a
hypercatabolic state.
Malnutrition intervention Available data demonstrates that early nutrition intervention, such
as adequate energy and protein to prevent loss of skeletal muscle, weight and subcutaneous
fat, can reduce complication rates, length of hospital stay (LOS), readmission rates,
mortality, and cost of care in malnourished patients undergoing major surgeries such as
gastrointestinal (GI) surgeries.
Studies suggest dietary leucine or its metabolite β-hydroxy β-methylbutyrate (HMB) can
improve skeletal muscle mass and function, as well as whole-body health and well-being of
animals and humans.
Supplementation with HMB has been extensively studied in elder patients and athletes. He X
and colleagues displayed that the effect of HMB is through increasing gene expression of
peroxisome proliferator-activated receptor gamma co-activator 1-alpha (PGC-1α), which is a
master regulator of mitochondrial metabolism (See HMB information sheet, attached). However,
no study has verified the effect of HMB on patients undergoing major surgeries.
HMB has been widely used in several over-the-counter products and supplements to improve
muscle function and increase lean body mass. One supplement containing HMB is Ensure Enlive.
This supplement is listed as the Abbott Company's most advanced nutrition shake and contains
high protein plus HMB. This supplement is designed to help reconstruct muscles from the
inside, with an all-in-one blend to support muscle, bone, heart immune, and digestive tract
health. It is specifically designed to help patients undergoing metabolic stress including
severe illness, injury, and surgery (See Ensure Enlive information sheet, attached).
The advantage of combining HMB with high protein nutrition supplement (Ensure Enlive) could
translate to the theory that, HMB is executed by increasing transcriptional level of protein
synthase, while other high protein or amino acids like Glutamine or Arginine supplements only
provide protein-amino acids pool for patients while body's preferred fuel during metabolic
stress is endogenous protein, rather than exogenous diet.
Hypotheses:
The investigators hypothesize that patients receiving high protein nutritional
supplementation with HMB (Ensure Enlive) will have meaningful improvements in surgical
outcomes rather than if they receive HMB only. Also, by comparing different methods of
malnutrition designation, the investigators are hypothesizing that by conduction of this
study, the investigators will have a better understanding of malnutrition and its
consequences in the Central Valley of California. Furthermore, the investigators are planning
to improve patient outcomes and significantly reduce the health care costs of the Valley by
proper nutritional supplementation.
Specific Aims:
1. Determine patients' nutritional status before and after major surgeries by baseline and
subsequent nutritional assessments
2. Determine the Resting Energy Expenditure (REE) in different phases of pre- and
postoperative periods using indirect calorimetry
3. Determine if at-risk for malnutrition is a major growing problem in the Central Valley
for patients undergoing major surgeries due to lack of screening tools by monitoring and
evaluating the Academy of Nutrition and Dietetics and the ASPEN recommendations for
diagnostic characteristics for adults at risk for malnutrition in routine clinical
practice including:
- Insufficient energy intake
- Weight Loss
- Loss of muscle mass
- Loss of subcutaneous fat
- Localized or generalized fluid accumulation that may sometimes mask weight loss
- Diminished functional status as measured by hand grip strength The presence of two
or more are necessary for the diagnosis of at risk for malnutrition
4. Compare serum protein markers and their ratios in order to correlate them with ASPEN's
and The Academy criteria for nutritional status quantification
5. Demonstrate the important role of leucine or its metabolite β-hydroxy β-methylbutyrate
(HMB) supplementation with or without high protein nutrition supplement in patients
undergoing major surgeries.
6. Also, this is a unique opportunity for Fresno State Food Science and Nutrition,
Nutrition and Dietetic undergraduate students to develop their skills and experience in
clinical practice and research. In this study, our undergraduate students will initiate
a full nutrition assessment analysis including all the 5 domains including client
history (CH), Anthropometric Measurements (AD), biochemical data, medical tests, and
procedures (BD), nutrition-focused/physical findings (PD) and Food/Nutrition-Related
History (FH), nutrition education session and also check the 6 criteria for
malnutrition, under the guidance of the researchers and registered dietitians, with the
use of intact protocols and standards of comparison.
The concept of malnutrition and its' effects on the outcomes of surgical patients was first
reported in 1936. A study revealed that malnourished patients going through ulcer surgery had
a 33 percent mortality rate when compared with 3.5 percent in well-nourished individuals.
According to the American Society of Parenteral and Enteral Nutrition (ASPEN) guidelines,
malnutrition is defined as 'an acute, subacute or chronic state of nutrition, in which
varying degrees of overnutrition or undernutrition with or without inflammatory activity have
led to a change in body composition and diminished function'.
Acute malnutrition is present in 25 to 54% of hospitalized patients at admission.
Malnutrition has a direct association with increased morbidity, mortality, length of stay
(LOS), increased readmissions and cost of care. A prospective study of 500 patients,
including 200 surgical patients, demonstrated that patients lost an average of 5.4 percent of
their body weight during their hospital stay. Also, the stress of surgery or trauma creates a
hypermetabolic state with an increased Basal Metabolic Rate (BMR) while raising protein and
energy requirements.
Furthermore, during illness, the metabolic demand, as well as recovery time, are increased.
This situation could increase the risk of malnutrition or shift it from at risk of
malnutrition to mild to moderate or even severe cases, resulting in a further increase in
subsequent recovery time. The aforementioned condition is more evident in major surgical
candidates because of metabolic stress leading to a general lack of desire to eat, malaise,
fatigue and oftentimes depression interrupting normal eating processes and food intake while
disturbing digestion and absorption. This condition results in skeletal muscle loss and usage
of internal amino acids for endogenous glucose production (Gluconeogenesis). With the loss of
skeletal muscle, protein and energy availability is lowered throughout the body. Muscle loss
is also associated with delayed recovery from illness after surgery, slow wound healing and
higher healthcare costs.
Measuring metabolic demand Given the increased caloric demand in a hypermetabolic state, the
patient requires increased energy. Determining the exact amount of energy required has proven
to be a moving target. Indirect calorimetry (IC), which is based on measurements of oxygen
and carbon dioxide production (see attachment), has been shown to be the gold standard for
Resting Energy Expenditure (REE) measurement in critically ill patients. However, this method
is often underutilized due to staff shortage, equipment costs, and lack of knowledge and
interpretation. Instead, predictive equations, such as the Mifflin St. Jeor, are used when
other more precise methods, such as IC, are not available. These predictive equations are
less precise, as they may not account for the increased demand due to the hypermetabolic
state of the patient undergoing major surgeries, whose metabolic demand can increase as much
as 150-200% above the Resting Energy Expenditure (REE). Therefore, the risk of inadequate
energy intake is increased in these patients.
Screening and diagnosis of malnutrition
A number of well-known tools such as the Mini Nutrition Assessment (MNA), Graz Malnutrition
Screening (GMS), Malnutrition Universal Screening Tool (MUST), Malnutrition Screening Tool
(MST) and Subjective Global Assessment (SGA) are available to identify malnutrition. Although
these tools have been validated, they can be limiting as they are self-directed and
malnourished patients rarely receive adequate nutritional assessment and treatment prior to
surgery. Instead, a recent expert consensus suggests that a diagnosis of malnutrition
requires that the patient exhibit two or more of the six Parenteral and Enteral Nutrition`s
(ASPEN) criteria for the diagnosis of malnutrition:
- Insufficient energy intake
- Weight loss
- Loss of muscle mass
- Loss of subcutaneous fat
- Localized or generalized fluid accumulation that may sometimes mask weight loss
- Diminished functional status as measured by hand grip strength Additionally, serum
proteins such as albumin, prealbumin (PAB) and C-Reactive Protein (CRP) have been widely
used by physicians as a marker for nutritional status. They provide a quantitative
measure to indirectly evaluate malnutrition and its severity in patients undergoing
surgery. Because of the overlap of malnutrition with chronic and acute inflammation, it
can be challenging to predict, as well as identify, malnutrition. Acute inflammation
seen in many chronic diseases could lead to hypermetabolism, rendering the patient in a
hypercatabolic state.
Malnutrition intervention Available data demonstrates that early nutrition intervention, such
as adequate energy and protein to prevent loss of skeletal muscle, weight and subcutaneous
fat, can reduce complication rates, length of hospital stay (LOS), readmission rates,
mortality, and cost of care in malnourished patients undergoing major surgeries such as
gastrointestinal (GI) surgeries.
Studies suggest dietary leucine or its metabolite β-hydroxy β-methylbutyrate (HMB) can
improve skeletal muscle mass and function, as well as whole-body health and well-being of
animals and humans.
Supplementation with HMB has been extensively studied in elder patients and athletes. He X
and colleagues displayed that the effect of HMB is through increasing gene expression of
peroxisome proliferator-activated receptor gamma co-activator 1-alpha (PGC-1α), which is a
master regulator of mitochondrial metabolism (See HMB information sheet, attached). However,
no study has verified the effect of HMB on patients undergoing major surgeries.
HMB has been widely used in several over-the-counter products and supplements to improve
muscle function and increase lean body mass. One supplement containing HMB is Ensure Enlive.
This supplement is listed as the Abbott Company's most advanced nutrition shake and contains
high protein plus HMB. This supplement is designed to help reconstruct muscles from the
inside, with an all-in-one blend to support muscle, bone, heart immune, and digestive tract
health. It is specifically designed to help patients undergoing metabolic stress including
severe illness, injury, and surgery (See Ensure Enlive information sheet, attached).
The advantage of combining HMB with high protein nutrition supplement (Ensure Enlive) could
translate to the theory that, HMB is executed by increasing transcriptional level of protein
synthase, while other high protein or amino acids like Glutamine or Arginine supplements only
provide protein-amino acids pool for patients while body's preferred fuel during metabolic
stress is endogenous protein, rather than exogenous diet.
Hypotheses:
The investigators hypothesize that patients receiving high protein nutritional
supplementation with HMB (Ensure Enlive) will have meaningful improvements in surgical
outcomes rather than if they receive HMB only. Also, by comparing different methods of
malnutrition designation, the investigators are hypothesizing that by conduction of this
study, the investigators will have a better understanding of malnutrition and its
consequences in the Central Valley of California. Furthermore, the investigators are planning
to improve patient outcomes and significantly reduce the health care costs of the Valley by
proper nutritional supplementation.
Specific Aims:
1. Determine patients' nutritional status before and after major surgeries by baseline and
subsequent nutritional assessments
2. Determine the Resting Energy Expenditure (REE) in different phases of pre- and
postoperative periods using indirect calorimetry
3. Determine if at-risk for malnutrition is a major growing problem in the Central Valley
for patients undergoing major surgeries due to lack of screening tools by monitoring and
evaluating the Academy of Nutrition and Dietetics and the ASPEN recommendations for
diagnostic characteristics for adults at risk for malnutrition in routine clinical
practice including:
- Insufficient energy intake
- Weight Loss
- Loss of muscle mass
- Loss of subcutaneous fat
- Localized or generalized fluid accumulation that may sometimes mask weight loss
- Diminished functional status as measured by hand grip strength The presence of two
or more are necessary for the diagnosis of at risk for malnutrition
4. Compare serum protein markers and their ratios in order to correlate them with ASPEN's
and The Academy criteria for nutritional status quantification
5. Demonstrate the important role of leucine or its metabolite β-hydroxy β-methylbutyrate
(HMB) supplementation with or without high protein nutrition supplement in patients
undergoing major surgeries.
6. Also, this is a unique opportunity for Fresno State Food Science and Nutrition,
Nutrition and Dietetic undergraduate students to develop their skills and experience in
clinical practice and research. In this study, our undergraduate students will initiate
a full nutrition assessment analysis including all the 5 domains including client
history (CH), Anthropometric Measurements (AD), biochemical data, medical tests, and
procedures (BD), nutrition-focused/physical findings (PD) and Food/Nutrition-Related
History (FH), nutrition education session and also check the 6 criteria for
malnutrition, under the guidance of the researchers and registered dietitians, with the
use of intact protocols and standards of comparison.
Inclusion Criteria:
- Dr. Amir Fathi as attending surgeon
- Adult patients (age >18) undergoing major abdominal and GI surgeries
- Patients at risk for malnutrition based on the ASPEN and The Academy malnutrition
criteria
Exclusion Criteria:
- Pediatric patients
- Patients undergoing chemotherapy or radiation
- Patients with a pacemaker (unable to conduct BIA)
- Patients unable to successfully complete the IC
- Patients with known allergies to products (Ensure Enlive, HMB)
- Patients that are unable to comply with all requirements
- Vegan patients
- Pregnant patients
- Prisoners
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