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

Phase 3

Completed

• Conditions: Right Ventricular Impaired Function; Hypovolemia
• Interventions: Drug: Ringer Lactate (10ml/kg) fluid expansion; Drug: Hypertonic saline (3ml/kg) fluid expansion

• Registration Number: NCT02782520
• Lead Sponsor: University Hospital, Grenoble

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-04-29
• Study First Submitted QC: 2016-05-24
• Study First Posted: 2016-05-25
• Study Start: 2016-08
• Primary Completion: 2017-10
• Study Completion: 2017-10
• Status Verified: 2017-11
• Last Update Submitted: 2018-04-26
• Last Update Posted: 2018-04-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Ringer Lactate	Ringer Lactate (10ml/kg) fluid expansion	Ringer Lactate group
Hypertonic saline	Hypertonic saline (3ml/kg) fluid expansion	Hypertonic saline group

Primary Outcome Measures

Name	Time	Method
Right ventricular ejection fraction change measured by Swan Ganz catheter.	after 30 minutes perfusion ( fluid expansion)

Secondary Outcome Measures

Name	Time	Method
Left ventricular contractility	at 30, 60 minutes and 3, 6 and 18 hours after perfusion
Plasmatic volume monitoring	One hour before and , 1, 6 and 18 hours after perfusion	Plasmatic volume augmentation assessed by hemoglobin decrease
Veinous oxygen saturation	at 30, 60 minutes and 3, 6 and 18 hours after perfusion
Mean arterial pressure assessment.	at 30, 60 minutes and 3, 6 and 18 hours after perfusion
Lactatemia level	at 1, 6 and 18 hours after perfusion
Acid base balance assessment.	at 1, 6 and 18 hours after perfusion
Tricuspid annular plane systolic excursion assessment	One hour before and after perfusion
Continuous cardiac output	at 30, 60 minutes and 3, 6 and 18 hours after perfusion
Blood volume efficiency	One hour before and 30, 60 minutes and 3, 6 and 18 hours after perfusion	Blood volume efficiency included : Right systolic and diastolic ventricular volumes, measured by swan ganz catheter, central veinous pressure
Natremia level	at 1, 6 and 18 hours after perfusion
Systolic volume change	at 30, 60 minutes and 3, 6 and 18 hours after perfusion
Cardiac output evolution.	at 30, 60 minutes and 3, 6 and 18 hours after perfusion

Trial Locations

Locations (1)

Reanimation Cardiovasculaire Et Thoracique; 🇫🇷 La Tronche, Grenoble, France