MedTrace Logo

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

NCT01981655 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 41

Last updated 2013-11-13

No results posted yet for this study

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.

Conditions

  • Acute Heart Failure

Interventions

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

Sponsors & Collaborators

  • Innogene Kalbiotech Pte. Ltd

    collaborator INDUSTRY

  • Nepean Blue Mountains Local Health District

    lead OTHER

Principal Investigators

  • Marek Nalos, MD · Dept. of Intensive Care, Nepean Hosp., U Sydney, Penrith, NSW, Australia

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-12-31
Primary Completion
2013-02-28
Completion
2013-08-31

Countries

  • Australia

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01981655 on ClinicalTrials.gov