NCT02782520

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Aug 2016

Shorter than P25 for phase_3

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 29, 2016

Completed
26 days until next milestone

First Posted

Study publicly available on registry

May 25, 2016

Completed
2 months until next milestone

Study Start

First participant enrolled

August 1, 2016

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2017

Completed
Last Updated

April 30, 2018

Status Verified

November 1, 2017

Enrollment Period

1.2 years

First QC Date

April 29, 2016

Last Update Submit

April 26, 2018

Conditions

Right Ventricular Impaired FunctionHypovolemia

Keywords

Cardiopulmonary bypassSwan GanzFluid expansionhypertonic saline solution

Outcome Measures

Primary Outcomes (1)

  • Right ventricular ejection fraction change measured by Swan Ganz catheter.

    after 30 minutes perfusion ( fluid expansion)

Secondary Outcomes (12)

  • 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

  • +7 more secondary outcomes

Study Arms (2)

Ringer Lactate

ACTIVE COMPARATOR

Ringer Lactate group

Drug: Ringer Lactate (10ml/kg) fluid expansion

Hypertonic saline

EXPERIMENTAL

Hypertonic saline group

Drug: Hypertonic saline (3ml/kg) fluid expansion

Interventions

Ringer Lactate (10ml/kg) fluid expansionDRUG
Ringer Lactate
Hypertonic saline (3ml/kg) fluid expansionDRUG
Hypertonic saline

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Pulmonary hypertension (SPAP \> 60mmHg)
  • No pre-operative sinus rhythm
  • Emergency surgery
  • Age \< 18 years
  • Chronic renal failure treated with dialysis
  • Severe hypernatremia

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Reanimation Cardiovasculaire Et Thoracique

La Tronche, Grenoble, 38043, France

Location

Related Publications (9)

  • 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.

    PMID: 10661697BACKGROUND

  • 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.

    PMID: 9257260BACKGROUND

  • 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.

    PMID: 3875003BACKGROUND

  • 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.

    PMID: 16426341BACKGROUND

  • 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.

    PMID: 7574010BACKGROUND

  • 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.

    PMID: 12181215BACKGROUND

  • 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.

    PMID: 2036225BACKGROUND

  • 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.

    PMID: 22197117BACKGROUND

  • 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.

    PMID: 23474659BACKGROUND

MeSH Terms

Conditions

Hypovolemia

Interventions

Ringer's LactateSaline Solution, Hypertonic

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Crystalloid SolutionsIsotonic SolutionsSolutionsPharmaceutical PreparationsHypertonic Solutions

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 29, 2016

First Posted

May 25, 2016

Study Start

August 1, 2016

Primary Completion

October 1, 2017

Study Completion

October 1, 2017

Last Updated

April 30, 2018

Record last verified: 2017-11

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)