NCT01981655

0.5M Na Lactate Solution in Acute Heart Failure (AHF)

A Phase 2, Randomised, Single-Blind, Placebo-controlled Study of Half Molar Sodium Lactate Solution in the Treatment of Subjects With Acute Heart Failure

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 41 (actual)
• Sponsor: Nepean Blue Mountains Local Health District · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The objective of this trial to see whether: -Cardiac performance (cardiac index and secondary outcomes)can be improved in patients with acute heart failure (AHF) and symptoms and consequences of fluid overload (pulmonary and interstitial edema) and poor peripheral perfusion can be reduced by: 1. Providing lactate as a substrate(Improve cardiac index) 2. Simultaneously restoring optimal preload Optimal standard treatment will be achieved in both arms with the use of current best treatment protocol for AHF as per independent treating physician. 4\. To assess effects of 0.5M Na lactate (Totilac) on plasma and urine biological parameters (sodium, potassium, chloride, pH, bicarb, base excess, albumin) 5\. To assess effects of 0.5M Na lactate on morbidity and mortality.

Detailed description

* Acute heart failure is a critical illness for which current treatments are suboptimal. * The various symptoms are related to inadequate cardiac output and usually include left ventricular overload with pulmonary oedema, interstitial fluid accumulation and tissue oedema (as indicated by frequent hyponatremia and hypoalbuminemia) and insufficient peripheral perfusion frequently manifesting as cold extremities and low urine output. * The current treatment of this syndrome is based on diuretics, vasodilators and/or inotropes, but fluid administration is also required to optimise the intravascular volume state and to reverse shock if present. Therefore management of body fluid balance remains a challenge since treatment aims to simultaneously maintain or improve intravascular volume and decrease body fluid excess and oedema. * The purpose of the present study is to assess in a prospective randomised trial the efficacy and safety of a newly designed crystalloid solution, 0.5 M sodium lactate, with properties potentially able to improve multiple pathophysiological aspects of AHF, as compared to the use of standard crystalloid solution Compound Sodium Lactate (mildly hypoosmolar \~ 274 mOsm/L and isotonic).

Conditions

• Acute Heart Failure

Interventions

Type	Name	Description
DRUG	0.5M Sodium lactate	A bolus of 0.5M Sodium lactate of 3 ml per kg BW is administered in 15 minutes, followed by a continuous infusion with 1 ml per kg per hour for 24 hours, i.e. in total 27 ml per kg over 24 hours
DRUG	Hartmann's solution	Hartmann's solution of 3 ml per kg BW is administered in 15 minutes, No infusion thereafter i.e. in total 3 ml per kg over 24 hours

Timeline

• Start date: 2009-12-01
• Primary completion: 2013-02-01
• Completion: 2013-08-01
• First posted: 2013-11-11
• Last updated: 2013-11-13

Locations

1 site across 1 country: Australia