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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT01981655




Registration number
NCT01981655
Ethics application status
Date submitted
13/08/2013
Date registered
11/11/2013
Date last updated
13/11/2013

Titles & IDs
Public title
0.5M Na Lactate Solution in Acute Heart Failure (AHF)
Scientific title
A Phase 2, Randomised, Single-Blind, Placebo-controlled Study of Half Molar Sodium Lactate Solution in the Treatment of Subjects With Acute Heart Failure
Secondary ID [1] 0 0
SOLACE1
Universal Trial Number (UTN)
Trial acronym
SOLACE1
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Acute Heart Failure 0 0
Condition category
Condition code
Cardiovascular 0 0 0 0
Coronary heart disease
Cardiovascular 0 0 0 0
Other cardiovascular diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - 0.5M Sodium lactate
Treatment: Drugs - Hartmann's solution

Experimental: 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

Active comparator: 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


Treatment: Drugs: 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

Treatment: Drugs: 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 code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Efficacy
Timepoint [1] 0 0
Baseline till 24 hours from first loading of study drug
Secondary outcome [1] 0 0
mortality
Timepoint [1] 0 0
up to 3 month
Secondary outcome [2] 0 0
acid base and electrolytes, fluid balance
Timepoint [2] 0 0
48 hours
Secondary outcome [3] 0 0
organ function
Timepoint [3] 0 0
48 hours

Eligibility
Key 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.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/12/2009
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/08/2013
Sample size
Target
Accrual to date
Final
41
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 0 0
Dept. of Intensive Care, Nepean Hosp., U Sydney - Penrith
Recruitment postcode(s) [1] 0 0
2751 - Penrith

Funding & Sponsors
Primary sponsor type
Other
Name
Nepean Blue Mountains Local Health District
Address
Country
Other collaborator category [1] 0 0
Commercial sector/industry
Name [1] 0 0
Innogene Kalbiotech Pte. Ltd
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/study/NCT01981655
Trial related presentations / publications
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.
Public notes

Contacts
Principal investigator
Name 0 0
Marek Nalos, MD
Address 0 0
Dept. of Intensive Care, Nepean Hosp., U Sydney, Penrith, NSW, Australia
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT01981655