CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 30 enrolled
Drug / intervention
Ringer Lactate (10ml/kg) fluid expansion +1 moredrug
Likely dose
Ringer Lactate (10ml/kg) fluid expansionfrom 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/NCT02782520
NCT02782520Phase 3Completed

Comparison of the Effects of an Hypertonic Solution With Ringer Lactate on Right Ventricular Function Following Cardiac Surgery

University Hospital, Grenoble·interventional·Posted May 25, 2016·Updated Apr 30, 2018

In Brief

A Phase 3 clinical trial evaluating Ringer Lactate (10ml/kg) fluid expansion and Hypertonic saline (3ml/kg) fluid expansion for Right Ventricular Impaired Function and Hypovolemia. Completed, enrolled 30 participants across 1 site.

Detailed Summary

This study is a phase III, randomized, controled, parallel groups, single blinded, clinical trial that aims at comparing the improvement of right ventricular function after administration of a hypertonic solution versus Ringer Lactate following cardiac surgery. Adults patients admitted to Grenoble University Hospital for elective cardiac surgery under cardiopulmonary bypass, in sinus rhythm and with Swan Ganz monitoring will be included. Patients needing fluid expansion in the first three hours after surgery will be randomized in two groups : one receiving Ringer Lactate (10 mL/kg), the other receiving hypertonic saline solution (3 mL/kg). Right ventricular function measured with Swan Ganz catheter, 30 minutes after fluid expansion will be the primary outcome.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesFrance
Collaborators--

Timeline

Phase 3CompletedFinished
2017201820192020202120222023202420252026
First PostedMay 25, 2016
Enrollment StartAug 1, 2016
Primary CompletionOct 1, 2017
TodayJul 2, 2026
Enrollment to primary: 1.2 yearsPosted 10.1 years ago

Interventions

Ringer Lactate (10ml/kg) fluid expansiondrug

Hypertonic saline (3ml/kg) fluid expansiondrug