Hypovolemia, Right Ventricular Impaired Function
Conditions
Keywords
Cardiopulmonary bypass, Swan Ganz, Fluid expansion, hypertonic saline solution
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.
Interventions
DRUGRinger Lactate (10ml/kg) fluid expansion
DRUGHypertonic saline (3ml/kg) fluid expansion
Sponsors
University Hospital, Grenoble
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Right ventricular ejection fraction change measured by Swan Ganz catheter. | after 30 minutes perfusion ( fluid expansion) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 | 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 |
| Left ventricular contractility | at 30, 60 minutes and 3, 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 | — |
| Plasmatic volume monitoring | One hour before and , 1, 6 and 18 hours after perfusion | Plasmatic volume augmentation assessed by hemoglobin decrease |
Countries
France
Outcome results
None listed