Effect of Goal-directed Crystalloid Versus Colloid Administration on Major Postoperative Morbidity
Overview
- Phase
- Not Applicable
- Intervention
- Crystalloid
- Conditions
- Postoperative Complications
- Sponsor
- The Cleveland Clinic
- Enrollment
- 1102
- Locations
- 3
- Primary Endpoint
- Number of Participants With Postoperative Morbidity (Major Complications)
- Status
- Completed
- Last Updated
- 7 years ago
Overview
Brief Summary
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.
Detailed 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.
Investigators
Eligibility Criteria
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.
Arms & Interventions
Crystalloid
Lactated Ringers solution will be used for fluid replacement.
Intervention: Crystalloid
Colloid
Low-molecular weight colloid HES 130/0.4 (Voluven) will be used for fluid replacement
Intervention: Colloid
Outcomes
Primary Outcomes
Number of Participants With Postoperative Morbidity (Major Complications)
Time Frame: Postoperative 30-days
Any of the following major complications: (1) Cardiac (Acute heart failure/Myocardial infarction/Ventricular arrhythmia); (2) pulmonary (embolism/edema/respiratory failure/pneumonia/pleural effusion); (3) gastrointestinal (bowel and surgical anastomosis stricture or anastomotic leak/internal or external fistulas/peritoneal effusions); (4) Renal (requiring dialysis); (5) Infectious (deep or organ space surgical site infection / sepsis); and (6) Coagulation (bleeding).
Secondary Outcomes
- Number of Participants With Postoperative Complications, 30-day Readmission, and 30-day Death(Postoperative 30 days)
- Number of Participants With Postoperative Acute Kidney Injury(Hospitalization)
- Number of Participants With Postoperative Morbidity (Minor Complications)(Postoperative 30-days)