NCT02782520

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: University Hospital, Grenoble · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Type	Name	Description
DRUG	Ringer Lactate (10ml/kg) fluid expansion
DRUG	Hypertonic saline (3ml/kg) fluid expansion

Timeline

• Start date: 2016-08-01
• Primary completion: 2017-10-01
• Completion: 2017-10-01
• First posted: 2016-05-25
• Last updated: 2018-04-30

Locations

1 site across 1 country: France