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

NCT01195883 ↗

Completed 1102 enrolled The Cleveland Clinic

RandomizedParallel-groupTriple-blindTreatment

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.

Timeline

Start: 2010-11
Primary completion: 2016-11
Completion: 2017-10-20

Outcome

Missed primary endpoint

registry analysis (superiority test); Crystalloid vs Colloid; p = 0.51; Risk Ratio (RR) 0.90 (95% CI 0.65 to 1.23); GEE model NCT01195883 ↗

Publications

Reiterer C, Kabon B, Taschner A, Zotti O, Kurz A, Fleischmann E. A comparison of intraoperative goal-directed intravenous administration of crystalloid versus colloid solutions on the postoperative maximum N-terminal pro brain natriuretic peptide in patients undergoing moderate- to high-risk noncardiac surgery. BMC Anesthesiol. 2020 Aug 4;20(1):192. doi: 10.1186/s12871-020-01104-9.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	hydroxyethyl starch	Other / unclassified	250 ml	Intravenous
Subject	lactated Ringer's solution	Unknown	250 ml	Intravenous

Indications

No indication recorded.