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

Primary Purpose

Right Ventricular Impaired Function, Hypovolemia

Status
Completed
Phase
Phase 3
Locations
France
Study Type
Interventional
Intervention
Ringer Lactate (10ml/kg) fluid expansion
Hypertonic saline (3ml/kg) fluid expansion
Sponsored by
University Hospital, Grenoble
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Right Ventricular Impaired Function focused on measuring Cardiopulmonary bypass, Swan Ganz, Fluid expansion, hypertonic saline solution

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Reanimation Cardiovasculaire Et Thoracique

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Ringer Lactate

Hypertonic saline

Arm Description

Ringer Lactate group

Hypertonic saline group

Outcomes

Primary Outcome Measures

Right ventricular ejection fraction change measured by Swan Ganz catheter.

Secondary Outcome Measures

Left ventricular contractility
Systolic volume change
Cardiac output evolution.
Tricuspid annular plane systolic excursion assessment
Continuous cardiac output
Blood volume efficiency
Blood volume efficiency included : Right systolic and diastolic ventricular volumes, measured by swan ganz catheter, central veinous pressure
Plasmatic volume monitoring
Plasmatic volume augmentation assessed by hemoglobin decrease
Natremia level
Veinous oxygen saturation
Mean arterial pressure assessment.
Lactatemia level
Acid base balance assessment.

Full Information

First Posted
April 29, 2016
Last Updated
April 26, 2018
Sponsor
University Hospital, Grenoble
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1. Study Identification

Unique Protocol Identification Number
NCT02782520
Brief Title
Comparison of the Effects of an Hypertonic Solution With Ringer Lactate on Right Ventricular Function Following Cardiac Surgery
Acronym
SUCCESS
Official Title
Comparison of the Effects of an Hypertonic Solution With Ringer Lactate on Right Ventricular Function Following Cardiac Surgery
Study Type
Interventional

2. Study Status

Record Verification Date
November 2017
Overall Recruitment Status
Completed
Study Start Date
August 2016 (Actual)
Primary Completion Date
October 2017 (Actual)
Study Completion Date
October 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Grenoble

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Right Ventricular Impaired Function, Hypovolemia
Keywords
Cardiopulmonary bypass, Swan Ganz, Fluid expansion, hypertonic saline solution

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Ringer Lactate
Arm Type
Active Comparator
Arm Description
Ringer Lactate group
Arm Title
Hypertonic saline
Arm Type
Experimental
Arm Description
Hypertonic saline group
Intervention Type
Drug
Intervention Name(s)
Ringer Lactate (10ml/kg) fluid expansion
Intervention Type
Drug
Intervention Name(s)
Hypertonic saline (3ml/kg) fluid expansion
Primary Outcome Measure Information:
Title
Right ventricular ejection fraction change measured by Swan Ganz catheter.
Time Frame
after 30 minutes perfusion ( fluid expansion)
Secondary Outcome Measure Information:
Title
Left ventricular contractility
Time Frame
at 30, 60 minutes and 3, 6 and 18 hours after perfusion
Title
Systolic volume change
Time Frame
at 30, 60 minutes and 3, 6 and 18 hours after perfusion
Title
Cardiac output evolution.
Time Frame
at 30, 60 minutes and 3, 6 and 18 hours after perfusion
Title
Tricuspid annular plane systolic excursion assessment
Time Frame
One hour before and after perfusion
Title
Continuous cardiac output
Time Frame
at 30, 60 minutes and 3, 6 and 18 hours after perfusion
Title
Blood volume efficiency
Description
Blood volume efficiency included : Right systolic and diastolic ventricular volumes, measured by swan ganz catheter, central veinous pressure
Time Frame
One hour before and 30, 60 minutes and 3, 6 and 18 hours after perfusion
Title
Plasmatic volume monitoring
Description
Plasmatic volume augmentation assessed by hemoglobin decrease
Time Frame
One hour before and , 1, 6 and 18 hours after perfusion
Title
Natremia level
Time Frame
at 1, 6 and 18 hours after perfusion
Title
Veinous oxygen saturation
Time Frame
at 30, 60 minutes and 3, 6 and 18 hours after perfusion
Title
Mean arterial pressure assessment.
Time Frame
at 30, 60 minutes and 3, 6 and 18 hours after perfusion
Title
Lactatemia level
Time Frame
at 1, 6 and 18 hours after perfusion
Title
Acid base balance assessment.
Time Frame
at 1, 6 and 18 hours after perfusion

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
Reanimation Cardiovasculaire Et Thoracique
City
La Tronche
State/Province
Grenoble
ZIP/Postal Code
38043
Country
France

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
10661697
Citation
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Results Reference
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PubMed Identifier
9257260
Citation
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.
Results Reference
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PubMed Identifier
3875003
Citation
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.
Results Reference
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PubMed Identifier
16426341
Citation
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.
Results Reference
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PubMed Identifier
7574010
Citation
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.
Results Reference
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PubMed Identifier
12181215
Citation
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.
Results Reference
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PubMed Identifier
2036225
Citation
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.
Results Reference
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PubMed Identifier
22197117
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.
Results Reference
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PubMed Identifier
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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.
Results Reference
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Comparison of the Effects of an Hypertonic Solution With Ringer Lactate on Right Ventricular Function Following Cardiac Surgery

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