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

Not Applicable

Completed

• Conditions: Postoperative Complications
• Interventions: Drug: Crystalloid; Drug: Colloid

• Registration Number: NCT01195883
• Lead Sponsor: The Cleveland Clinic

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.

Study Timeline

• Study First Submitted: 2010-09-03
• Study First Submitted QC: 2010-09-03
• Study First Posted: 2010-09-06
• Study Start: 2010-11
• Primary Completion: 2016-11
• Study Completion: 2017-10-20
• Results First Submitted: 2018-05-17
• Status Verified: 2018-07
• Results First Submitted QC: 2018-07-23
• Results First Posted: 2018-08-21
• Last Update Submitted: 2018-10-01
• Last Update Posted: 2018-10-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1102

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Crystalloid	Crystalloid	Lactated Ringers solution will be used for fluid replacement.
Colloid	Colloid	Low-molecular weight colloid HES 130/0.4 (Voluven) will be used for fluid replacement

Primary Outcome Measures

Name	Time	Method
Number of Participants With Postoperative Morbidity (Major Complications)	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 Outcome Measures

Name	Time	Method
Number of Participants With Postoperative Complications, 30-day Readmission, and 30-day Death	Postoperative 30 days	A composite of the primary outcome, and readmission and death.
Number of Participants With Postoperative Acute Kidney Injury	Hospitalization	Preoperative-to-postoperative change in AKIN stage
Number of Participants With Postoperative Morbidity (Minor Complications)	Postoperative 30-days	Any of the following minor complications: (1) unplanned ICU admission; (2) unplanned operation; (3) cardiac (ischemia/non-ventricular arrhythmia/hemodynamic disturbances); (4) pulmonary effusion; (5) deep venous thrombosis; (6) gastrointestinal (effusion/gut paralysis); (7) progressive renal insufficiency; (8) infection (superficial/fever/cystitis or urinary tract infection); and (9) transient neurological injury.

Trial Locations

Locations (3)

Cleveland Clinic Hillcrest Hospital; 🇺🇸 Mayfield Heights, Ohio, United States

Cleveland Clinic Foundation; 🇺🇸 Cleveland, Ohio, United States

Medical University of Vienna; 🇦🇹 Vienna, Austria