Effect of Goal-directed Crystalloid Versus Colloid Administration on Major Postoperative Morbidity

Status:	Completed
Conditions:	Hospital
Therapuetic Areas:	Other
Healthy:	No
Age Range:	18 - 80
Updated:	11/1/2018
Start Date:	November 2010
End Date:	October 20, 2017

A trial in which patients having open abdominal surgery are randomized to receive either
crystalloids or colloids intraoperatively, guided by esophageal Doppler. The investigators
test the primary hypothesis that goal-directed colloid administration during elective
abdominal surgery decreases a composite of postoperative complications within 30 days of
surgery.

Patients will be given 5-7 ml/kg of crystalloid (lactated Ringer's) in the immediate
preoperative period, which will be followed by 4 ml/kg/h crystalloid for maintenance
normalized to ideal body weight [Men: Ideal Body Weight (in kilograms) = 52 kg + 1.9 kg for
every 2.5 cm over 150 cm; Women: Ideal Body Weight (in kilograms) = 49 kg + 1.7 kg for every
2.5 cm over 150 cm].

They will then be randomly assigned to additional volume replacement, guided by esophageal
Doppler, to either lactated Ringer's solution of Voluven starch.

Inclusion Criteria:

- ASA Physical Status 1-3

- Body Mass Index < 35

- Moderate risk elective abdominal surgical procedures scheduled to take ≥ two hours
done under general anesthesia.

Exclusion Criteria:

- cardiac insufficiency (EF<35%)

- coronary disease with angina (NYHA IV)

- severe chronic obstructive pulmonary disease

- coagulopathies

- symptoms of infection or sepsis

- renal insufficiency (creatinine clearance <30ml/min or renal replacement therapy)

- ASA Physical Status > 3.

We found this trial at

sites

Cleveland Clinic/Hillcrest Hospital

Mayfield Heights, Ohio 44124

Phone: 440-312-5259

from

Mayfield Heights, OH