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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
Trial website
Trial related presentations / publications
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

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results not provided in https://clinicaltrials.gov/study/NCT01981655