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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/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)
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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
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Secondary ID [1]
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SOLACE1
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Universal Trial Number (UTN)
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Trial acronym
SOLACE1
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Acute Heart Failure
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Condition category
Condition code
Cardiovascular
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Coronary heart disease
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Cardiovascular
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Other cardiovascular diseases
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Intervention/exposure
Study type
Interventional
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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
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Efficacy
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Assessment method [1]
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Improvement in cardiac output measured by transthoracic echocardiography at 24 hours from initiation of study drug infusion
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Timepoint [1]
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Baseline till 24 hours from first loading of study drug
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Secondary outcome [1]
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mortality
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Assessment method [1]
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range of efficacy and safety parameters
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Timepoint [1]
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up to 3 month
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Secondary outcome [2]
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acid base and electrolytes, fluid balance
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Assessment method [2]
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the effect on on pH, base excess, bicarbonate, sodium, potassium, phosphate, chloride and lactate will be assessed during the study period
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Timepoint [2]
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48 hours
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Secondary outcome [3]
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organ function
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Assessment method [3]
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effect on respiratory function assessed by time on ventilatory support and renal function measured by creatinine level over 48 hours will be assessed
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Timepoint [3]
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48 hours
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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.
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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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
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 2
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
1/12/2009
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
1/08/2013
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Sample size
Target
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Accrual to date
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Final
41
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Recruitment in Australia
Recruitment state(s)
NSW
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Recruitment hospital [1]
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Dept. of Intensive Care, Nepean Hosp., U Sydney - Penrith
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Recruitment postcode(s) [1]
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2751 - Penrith
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Funding & Sponsors
Primary sponsor type
Other
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Name
Nepean Blue Mountains Local Health District
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Address
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Country
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Other collaborator category [1]
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Commercial sector/Industry
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Name [1]
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Innogene Kalbiotech Pte. Ltd
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Address [1]
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Country [1]
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Ethics approval
Ethics application status
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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.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT01981655
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Marek Nalos, MD
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Address
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Dept. of Intensive Care, Nepean Hosp., U Sydney, Penrith, NSW, Australia
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Address
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Country
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Phone
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Fax
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Email
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT01981655
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