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

NeuroTherapia, Inc.

Status

Completed

Conditions

Postoperative Complications

Treatments

Drug: Crystalloid

Drug: Colloid

Study type

Interventional

Funder types

Other

Identifiers

NCT01195883

09-1051

Details and patient eligibility

About

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.

Full description

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.

Enrollment

1,102 patients

Sex

All

Ages

18 to 80 years old

Volunteers

No Healthy Volunteers

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.