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

NCT ID: NCT01981655

Last Updated: 2013-11-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 41 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-12-31
• Study Completion Date: 2013-08-31

Brief 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

Keywords

Sodium Lactate; Acute; Heart; Failure; Perfusion

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

0.5M Sodium lactate

A bolus of 0.5M Sodium lactate of 3 ml per kg body weight (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

Group Type: EXPERIMENTAL

0.5M Sodium lactate

Intervention Type: DRUG

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

Hartmann's solution

Hartmann's solution of 3 ml per kg BW is administered in 15 minutes. There is NO continuous infusion infused thereafter; i.e. in total 3 ml per kg over 24 hours

Group Type: ACTIVE_COMPARATOR

Hartmann's solution

Intervention Type: DRUG

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

Interventions

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

Intervention Type: 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

Intervention Type: DRUG

Other Intervention Names

Totilac; Compound Sodium Lactate

Eligibility Criteria

Inclusion Criteria

• Age: more than 18 years
• Heart failure criteria:

Left heart failure: as evidenced by 2 out of 3:

• Left ventricular ejection fraction (LVEF) ≤ 40% and cardiac index ≤ 2.5 L/min/m2
• Acute pulmonary oedema of cardiac origin or mechanical ventilation (including CPAP/BIPAP) for respiratory failure of predominantly cardiac origin
• Need for inotropes/vasopressors for cardiac pump failure OR

Right heart failure: as evidenced by 1 out of 2:

• Bilateral leg oedema above ankles
• RV failure (low tricuspid annular plane systolic excursion (TAPSE), dilated floppy RV)
• Poor peripheral perfusion as evidenced by 2 out of 3:

Cold mottled skin Low urine output Acutely clouded sensorium/poor mentation

• Consent obtained from patient or patient's next of kin.

Exclusion Criteria

• Hypernatremia: [Na] >145 mmol/L
• Diagnosed hypertrophic obstructive cardiomyopathy
• Uncorrected severe valvular heart disease
• Documented third degree heart block, sustained ventricular tachycardia
• Documented cardiac tamponade
• Septic shock
• Acute respiratory distress syndrome (ARDS)
• Moribund patients likely to die before 24h
• Patients with major diseases of limited prognosis such as end stage cancer,end-stage liver failure, end stage dialysis dependent renal failure
• Patients with absolute indication for acute hemodialysis/hemofiltration (pH, K, urea > 35 mmol/L, severe fluid overload in the presence of oliguria < 200 mL/6h.
• Known pregnancy

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Innogene Kalbiotech Pte. Ltd

INDUSTRY

Sponsor Role: collaborator

Nepean Blue Mountains Local Health District

OTHER

Sponsor Role: lead

Responsible Party

Marek Nalos

Staff Specialist, Intensive Care Medicine

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Marek Nalos, MD

Role: PRINCIPAL_INVESTIGATOR

Dept. of Intensive Care, Nepean Hosp., U Sydney, Penrith, NSW, Australia

Locations

Dept. of Intensive Care, Nepean Hosp., U Sydney

Penrith, New South Wales, Australia

Countries

Australia

References

Nalos M, Leverve X, Huang S, Weisbrodt L, Parkin R, Seppelt I, Ting I, Mclean A. Half-molar sodium lactate infusion improves cardiac performance in acute heart failure: a pilot randomised controlled clinical trial. Crit Care. 2014 Mar 25;18(2):R48. doi: 10.1186/cc13793.

Reference Type: DERIVED

PMID: 24666826 (View on PubMed)

Other Identifiers

SOLACE1

Identifier Type: -

Identifier Source: org_study_id