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

Study Overview
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Brief Summary
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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.

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

Conditions
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Hypovolemia, Right Ventricular Impaired Function

Intervention / Treatment
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* Drug: Ringer Lactate (10ml/kg) fluid expansion
* Drug: Hypertonic saline (3ml/kg) fluid expansion


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Ringer Lactate<br>Ringer Lactate group | Drug: Ringer Lactate (10ml/kg) fluid expansion<br> <br> |
| Experimental: Hypertonic saline<br>Hypertonic saline group | Drug: Hypertonic saline (3ml/kg) fluid expansion<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Right ventricular ejection fraction change measured by Swan Ganz catheter. |  | after 30 minutes perfusion ( fluid expansion) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Left ventricular contractility |  | at 30, 60 minutes and 3, 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 | 
| 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 | Blood volume efficiency included : Right systolic and diastolic ventricular volumes, measured by swan ganz catheter, central veinous pressure | One hour before and 30, 60 minutes and 3, 6 and 18 hours after perfusion | 
| Plasmatic volume monitoring | Plasmatic volume augmentation assessed by hemoglobin decrease | One hour before and , 1, 6 and 18 hours after perfusion | 
| Natremia level |  | at 1, 6 and 18 hours after perfusion | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cardiopulmonary bypass, Swan Ganz, Fluid expansion, hypertonic saline solution