CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 1,109 enrolled
Drug / intervention
Lactated Ringer's Solution +1 moredrug
Likely dose
Lactated Ringer's Solution 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/NCT00517127
NCT00517127Phase 4Completed
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A Comparison of Crystalloids vs. Colloids for Intraoperative Goal-directed Fluid Management

Medical University of Vienna·interventional·Posted Aug 16, 2007·Updated Jan 10, 2018

In Brief

A Phase 4 clinical trial evaluating Lactated Ringer's Solution and Hydroxyethylstarch 6% 130/0.4 for Fluid Overload and Postoperative Complications. Completed, enrolled 1,109 participants across 1 site.

Detailed Summary

The purpose of the study is to test whether colloid-based goal-directed intraoperative fluid management leads to less perioperative morbidity compared to crystalloid-based goal-directed intraoperative fluid management. Goal-directed therapy is based on measurements by an Esophageal Doppler Device.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsFluid Overload, Postoperative Complications
CountriesAustria
CollaboratorsFresenius Kabi

Timeline

Phase 4CompletedFinished
200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedAug 16, 2007
Enrollment StartSep 1, 2006
Primary CompletionDec 31, 2016
TodayJul 2, 2026
Enrollment to primary: 10.3 yearsPosted 18.9 years ago

Interventions

Lactated Ringer's Solutiondrug

Arm Nr 1: If corrected flow time (fTc), measured by esophageal doppler, falls below 350 msec, 250 ml of Lactated Ringer's Solution will be administered.

Hydroxyethylstarch 6% 130/0.4drug

Arm Nr 2: If corrected flow time (fTc), measured by esophageal doppler, falls below 350 msec, 250 ml of Hydroxyethylstarch 6% 130/0.4 will be administered.