NCT01981655

Brief Summary

The objective of this trial to see whether:

  1. 1.Providing lactate as a substrate(Improve cardiac index)
  2. 2.Simultaneously restoring optimal preload

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
41

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Dec 2009

Typical duration for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2009

Completed
3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2013

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2013

Completed
12 days until next milestone

First Submitted

Initial submission to the registry

August 13, 2013

Completed
3 months until next milestone

First Posted

Study publicly available on registry

November 11, 2013

Completed
Last Updated

November 13, 2013

Status Verified

November 1, 2013

Enrollment Period

3.2 years

First QC Date

August 13, 2013

Last Update Submit

November 9, 2013

Conditions

Acute Heart Failure

Keywords

Sodium LactateAcuteHeartFailurePerfusion

Outcome Measures

Primary Outcomes (1)

  • Efficacy

    Improvement in cardiac output measured by transthoracic echocardiography at 24 hours from initiation of study drug infusion

    Baseline till 24 hours from first loading of study drug

Secondary Outcomes (3)

  • mortality

    up to 3 month

  • acid base and electrolytes, fluid balance

    48 hours

  • organ function

    48 hours

Study Arms (2)

0.5M Sodium lactate

EXPERIMENTAL

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

Drug: 0.5M Sodium lactate

Hartmann's solution

ACTIVE COMPARATOR

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

Drug: Hartmann's solution

Interventions

0.5M Sodium lactateDRUG

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

Also known as: Totilac
0.5M Sodium lactate
Hartmann's solutionDRUG

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

Also known as: Compound Sodium Lactate
Hartmann's solution

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Penrith, New South Wales, 2751, Australia

Location

Related Publications (1)

  • 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.

    PMID: 24666826DERIVED

MeSH Terms

Interventions

Sodium LactateRinger's Lactate

Intervention Hierarchy (Ancestors)

LactatesHydroxy AcidsCarboxylic AcidsOrganic ChemicalsCrystalloid SolutionsIsotonic SolutionsSolutionsPharmaceutical Preparations

Study Officials

  • Marek Nalos, MD

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

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Staff Specialist, Intensive Care Medicine

Study Record Dates

First Submitted

August 13, 2013

First Posted

November 11, 2013

Study Start

December 1, 2009

Primary Completion

February 1, 2013

Study Completion

August 1, 2013

Last Updated

November 13, 2013

Record last verified: 2013-11

Locations

AU(1)