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

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.

Timeline

Start

2016-08

Primary completion

2017-10

Completion

2017-10

Publications

• Background Kaul TK, Fields BL. Postoperative acute refractory right ventricular failure: incidence, pathogenesis, management and prognosis. Cardiovasc Surg. 2000 Jan;8(1):1-9. doi: 10.1177/096721090000800101.
• Background 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.
• Background 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.
• Background 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.
• Background 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.
• Background 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.
• Background 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.
• Background 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.
• Background 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.

Drugs

Indications

No indication recorded.