Clinical trial NCT02782520: Comparison of the Effects of an Hypertonic Solution With Ringer Lactate on Right Ventricular Function Following Cardiac Surgery
Official title: Comparison of the Effects of an Hypertonic Solution With Ringer Lactate on Right Ventricular Function Following Cardiac Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Right Ventricular Impaired Function
Hypovolemia
Keywords: Cardiopulmonary bypass
Swan Ganz
Fluid expansion
hypertonic saline solution
Lead sponsor: University Hospital, Grenoble
Sponsor class: OTHER
First posted: 2016-05-25
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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

Primary outcomes:
measure: Right ventricular ejection fraction change measured by Swan Ganz catheter.
timeFrame: after 30 minutes perfusion ( fluid expansion)
Secondary outcomes:
measure: Left ventricular contractility
timeFrame: at 30, 60 minutes and 3, 6 and 18 hours after perfusion
measure: Systolic volume change
timeFrame: at 30, 60 minutes and 3, 6 and 18 hours after perfusion
measure: Cardiac output evolution.
timeFrame: at 30, 60 minutes and 3, 6 and 18 hours after perfusion
measure: Tricuspid annular plane systolic excursion assessment
timeFrame: One hour before and after perfusion
measure: Continuous cardiac output
timeFrame: at 30, 60 minutes and 3, 6 and 18 hours after perfusion
measure: Blood volume efficiency
timeFrame: One hour before and 30, 60 minutes and 3, 6 and 18 hours after perfusion
measure: Plasmatic volume monitoring
timeFrame: One hour before and , 1, 6 and 18 hours after perfusion
measure: Natremia level
timeFrame: at 1, 6 and 18 hours after perfusion
measure: Veinous oxygen saturation
timeFrame: at 30, 60 minutes and 3, 6 and 18 hours after perfusion
measure: Mean arterial pressure assessment.
timeFrame: at 30, 60 minutes and 3, 6 and 18 hours after perfusion
measure: Lactatemia level
timeFrame: at 1, 6 and 18 hours after perfusion
measure: Acid base balance assessment.
timeFrame: at 1, 6 and 18 hours after perfusion
Other outcomes:
Locations:
city: La Tronche
country: France
facility: Reanimation Cardiovasculaire Et Thoracique
state: Grenoble
Study officials:
References:
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citation: Romano SM. Cardiac cycle efficiency: a new parameter able to fully evaluate the dynamic interplay of the cardiovascular system. Int J Cardiol. 2012 Mar 8;155(2):326-7. doi: 10.1016/j.ijcard.2011.12.008. Epub 2011 Dec 22. No abstract available.
citation: Scolletta S, Bodson L, Donadello K, Taccone FS, Devigili A, Vincent JL, De Backer D. Assessment of left ventricular function by pulse wave analysis in critically ill patients. Intensive Care Med. 2013 Jun;39(6):1025-33. doi: 10.1007/s00134-013-2861-8. Epub 2013 Mar 9.