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

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.

Study Overview

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

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Phase 3

Contacts and Locations

Study Locations

• France
  • Grenoble
    • La Tronche, Grenoble, France, 38043
      • Reanimation Cardiovasculaire Et Thoracique

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: University Hospital, Grenoble

Publications and helpful links

General Publications

• Kaul TK, Fields BL. Postoperative acute refractory right ventricular failure: incidence, pathogenesis, management and prognosis. Cardiovasc Surg. 2000 Jan;8(1):1-9. doi: 10.1016/s0967-2109(99)00089-7.
• Gavazzi A, Berzuini C, Campana C, Inserra C, Ponzetta M, Sebastiani R, Ghio S, Recusani F. Value of right ventricular ejection fraction in predicting short-term prognosis of patients with severe chronic heart failure. J Heart Lung Transplant. 1997 Jul;16(7):774-85.
• Christakis GT, Fremes SE, Weisel RD, Ivanov J, Madonik MM, Seawright SJ, McLaughlin PR. Right ventricular dysfunction following cold potassium cardioplegia. J Thorac Cardiovasc Surg. 1985 Aug;90(2):243-50.
• Durand M, Chavanon O, Tessier Y, Casez M, Gardellin M, Blin D, Girardet P. Right ventricular function after coronary surgery with or without bypass. J Card Surg. 2006 Jan-Feb;21(1):11-6. doi: 10.1111/j.1540-8191.2006.00161.x.
• Mouren S, Delayance S, Mion G, Souktani R, Fellahi JL, Arthaud M, Baron JF, Viars P. Mechanisms of increased myocardial contractility with hypertonic saline solutions in isolated blood-perfused rabbit hearts. Anesth Analg. 1995 Oct;81(4):777-82. doi: 10.1097/00000539-199510000-00021.
• Ueti OM, Camargo EE, Ueti Ade A, de Lima-Filho EC, Nogueira EA. Assessment of right ventricular function with Doppler echocardiographic indices derived from tricuspid annular motion: comparison with radionuclide angiography. Heart. 2002 Sep;88(3):244-8. doi: 10.1136/heart.88.3.244.
• Hammarstrom E, Wranne B, Pinto FJ, Puryear J, Popp RL. Tricuspid annular motion. J Am Soc Echocardiogr. 1991 Mar-Apr;4(2):131-9. doi: 10.1016/s0894-7317(14)80524-5.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2016
• Primary Completion (Actual): October 1, 2017
• Study Completion (Actual): October 1, 2017

Study Registration Dates

• First Submitted: April 29, 2016
• First Submitted That Met QC Criteria: May 24, 2016
• First Posted (Estimate): May 25, 2016

Study Record Updates

• Last Update Posted (Actual): April 30, 2018
• Last Update Submitted That Met QC Criteria: April 26, 2018
• Last Verified: November 1, 2017

More Information

Terms related to this study

• Keywords: Cardiopulmonary bypass; Swan Ganz; Fluid expansion; hypertonic saline solution
• Additional Relevant MeSH Terms: Pathologic Processes; Hypovolemia
• Other Study ID Numbers: 38RC15.214

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No