CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 1,102 enrolled
Drug / intervention
Crystalloid +1 moredrug
Likely dose
Crystalloid 250 mlfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01195883
NCT01195883N/ACompleted
CompareCT.gov

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

The Cleveland Clinic·interventional·Posted Sep 6, 2010·Updated Oct 30, 2018

In Brief

A clinical study evaluating Crystalloid and Colloid for Postoperative Complications. Completed, enrolled 1,102 participants across 3 sites in 2 countries.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPostoperative Complications
CountriesAustria, United States
Collaborators--

Timeline

N/ACompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedSep 6, 2010
Enrollment StartNov 1, 2010
Primary CompletionNov 1, 2016
Study CompletionOct 20, 2017
TodayJul 2, 2026
Enrollment to primary: 6 yearsPosted 15.8 years ago

Interventions

Crystalloiddrug

For goal directed volume management we use corrected aortic flow time (FTc) and stroke volume derived from esophageal Doppler as in previous studies. In case of hypovolemia, detected by esophageal Doppler monitoring (CardioQ, Deltex Medical Group PLC, Chichester, UK) according to a previously published algorithm, an additional fluid bolus of 250 ml of LR will be given over a period of 5 minutes.

Colloiddrug

For goal directed volume management we use corrected aortic flow time (FTc) and stroke volume derived from esophageal Doppler as in previous studies. In case of hypovolemia, detected by esophageal Doppler monitoring (CardioQ, Deltex Medical Group PLC, Chichester, UK) according to a previously published algorithm, an additional fluid bolus of 250 ml of Hydroxyethylstarch 6% 130/0.4 (Voluven®Fresenius-Kabi, Bad Homburg, Germany) will be given over a period of 5 minutes.