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

NCT02782520 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2018-04-30

No results posted yet for this study

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.

Conditions

  • Right Ventricular Impaired Function
  • Hypovolemia

Interventions

DRUG

Ringer Lactate (10ml/kg) fluid expansion

DRUG

Hypertonic saline (3ml/kg) fluid expansion

Sponsors & Collaborators

  • University Hospital, Grenoble

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-08-31
Primary Completion
2017-10-31
Completion
2017-10-31

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02782520 on ClinicalTrials.gov