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

• Status: Completed
• Trial end date: 2017-10-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University Hospital, Grenoble
• Treatments: Pharmaceutical Solutions

Criteria

Inclusion Criteria:

• Elective valvular or coronary surgery

• Under cardiopulmonary bypass

• Patient requiring Swan Ganz catheter monitoring

• Patient in sinus rhythm

• Patient requiring post-operative volemic expansion

• Echographic criteria of hypovolemia, without hypervolemia

Exclusion Criteria:

• Pulmonary hypertension (SPAP > 60mmHg)

• No pre-operative sinus rhythm

• Emergency surgery

• Age < 18 years

• Chronic renal failure treated with dialysis

• Severe hypernatremia