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

Hypovolemia Clinical Trial

— SUCCESS  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02782520
• Other study ID #: 38RC15.214
• Status: Completed
• Phase: Phase 3
• Start date: August 2016
• Est. completion date: October 2017

Study information

• Verified date: November 2017
• Source: University Hospital, Grenoble
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: October 2017
• Est. primary completion date: October 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Hypovolemia
• Right Ventricular Impaired Function

Intervention

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

• Hypertonic saline (3ml/kg) fluid expansion

Locations

Country	Name	City	State
France	Reanimation Cardiovasculaire Et Thoracique	La Tronche	Grenoble

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Grenoble

Country where clinical trial is conducted

France, 

References & Publications (9)

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. — View 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. — View 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. — View Citation

Hammarström E, Wranne B, Pinto FJ, Puryear J, Popp RL. Tricuspid annular motion. J Am Soc Echocardiogr. 1991 Mar-Apr;4(2):131-9. — View Citation

Kaul TK, Fields BL. Postoperative acute refractory right ventricular failure: incidence, pathogenesis, management and prognosis. Cardiovasc Surg. 2000 Jan;8(1):1-9. Review. — View 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. — View 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Right ventricular ejection fraction change measured by Swan Ganz catheter.		after 30 minutes perfusion ( fluid expansion)
Secondary	Left ventricular contractility		at 30, 60 minutes and 3, 6 and 18 hours after perfusion
Secondary	Systolic volume change		at 30, 60 minutes and 3, 6 and 18 hours after perfusion
Secondary	Cardiac output evolution.		at 30, 60 minutes and 3, 6 and 18 hours after perfusion
Secondary	Tricuspid annular plane systolic excursion assessment		One hour before and after perfusion
Secondary	Continuous cardiac output		at 30, 60 minutes and 3, 6 and 18 hours after perfusion
Secondary	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
Secondary	Plasmatic volume monitoring	Plasmatic volume augmentation assessed by hemoglobin decrease	One hour before and , 1, 6 and 18 hours after perfusion
Secondary	Natremia level		at 1, 6 and 18 hours after perfusion
Secondary	Veinous oxygen saturation		at 30, 60 minutes and 3, 6 and 18 hours after perfusion
Secondary	Mean arterial pressure assessment.		at 30, 60 minutes and 3, 6 and 18 hours after perfusion
Secondary	Lactatemia level		at 1, 6 and 18 hours after perfusion
Secondary	Acid base balance assessment.		at 1, 6 and 18 hours after perfusion