Back to results0.5M Na Lactate Solution in Acute Heart Failure (AHF) (SOLACE1)
Primary Purpose
Acute Heart Failure
Status
Completed
Phase
Phase 2
Locations
Australia
Study Type
Interventional
Intervention
0.5M Sodium lactate
Hartmann's solution
Sponsored by
About this trial
This is an interventional treatment trial for Acute Heart Failure focused on measuring Sodium Lactate, Acute, Heart, Failure, Perfusion
Eligibility Criteria
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.
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
Sites / Locations
- Dept. of Intensive Care, Nepean Hosp., U Sydney
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
0.5M Sodium lactate
Hartmann's solution
Arm Description
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
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
Outcomes
Primary Outcome Measures
Efficacy
Improvement in cardiac output measured by transthoracic echocardiography at 24 hours from initiation of study drug infusion
Secondary Outcome Measures
mortality
range of efficacy and safety parameters
acid base and electrolytes, fluid balance
the effect on on pH, base excess, bicarbonate, sodium, potassium, phosphate, chloride and lactate will be assessed during the study period
organ function
effect on respiratory function assessed by time on ventilatory support and renal function measured by creatinine level over 48 hours will be assessed
Full Information
NCT ID
NCT01981655
First Posted
August 13, 2013
Last Updated
November 9, 2013
Sponsor
Nepean Blue Mountains Local Health District
Collaborators
Innogene Kalbiotech Pte. Ltd
1. Study Identification
Unique Protocol Identification Number
NCT01981655
Brief Title
0.5M Na Lactate Solution in Acute Heart Failure (AHF)
Acronym
SOLACE1
Official 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
Study Type
Interventional
2. Study Status
Record Verification Date
November 2013
Overall Recruitment Status
Completed
Study Start Date
December 2009 (undefined)
Primary Completion Date
February 2013 (Actual)
Study Completion Date
August 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Nepean Blue Mountains Local Health District
Collaborators
Innogene Kalbiotech Pte. Ltd
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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:
Providing lactate as a substrate(Improve cardiac index)
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.
Detailed Description
Acute heart failure is a critical illness for which current treatments are suboptimal.
The various symptoms are related to inadequate cardiac output and usually include left ventricular overload with pulmonary oedema, interstitial fluid accumulation and tissue oedema (as indicated by frequent hyponatremia and hypoalbuminemia) and insufficient peripheral perfusion frequently manifesting as cold extremities and low urine output.
The current treatment of this syndrome is based on diuretics, vasodilators and/or inotropes, but fluid administration is also required to optimise the intravascular volume state and to reverse shock if present. Therefore management of body fluid balance remains a challenge since treatment aims to simultaneously maintain or improve intravascular volume and decrease body fluid excess and oedema.
The purpose of the present study is to assess in a prospective randomised trial the efficacy and safety of a newly designed crystalloid solution, 0.5 M sodium lactate, with properties potentially able to improve multiple pathophysiological aspects of AHF, as compared to the use of standard crystalloid solution Compound Sodium Lactate (mildly hypoosmolar ~ 274 mOsm/L and isotonic).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Heart Failure
Keywords
Sodium Lactate, Acute, Heart, Failure, Perfusion
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
41 (Actual)
8. Arms, Groups, and Interventions
Arm Title
0.5M Sodium lactate
Arm Type
Experimental
Arm Description
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
Arm Title
Hartmann's solution
Arm Type
Active Comparator
Arm Description
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
Intervention Type
Drug
Intervention Name(s)
0.5M Sodium lactate
Other Intervention Name(s)
Totilac
Intervention Description
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
Intervention Type
Drug
Intervention Name(s)
Hartmann's solution
Other Intervention Name(s)
Compound Sodium Lactate
Intervention Description
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
Primary Outcome Measure Information:
Title
Efficacy
Description
Improvement in cardiac output measured by transthoracic echocardiography at 24 hours from initiation of study drug infusion
Time Frame
Baseline till 24 hours from first loading of study drug
Secondary Outcome Measure Information:
Title
mortality
Description
range of efficacy and safety parameters
Time Frame
up to 3 month
Title
acid base and electrolytes, fluid balance
Description
the effect on on pH, base excess, bicarbonate, sodium, potassium, phosphate, chloride and lactate will be assessed during the study period
Time Frame
48 hours
Title
organ function
Description
effect on respiratory function assessed by time on ventilatory support and renal function measured by creatinine level over 48 hours will be assessed
Time Frame
48 hours
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marek Nalos, MD
Organizational Affiliation
Dept. of Intensive Care, Nepean Hosp., U Sydney, Penrith, NSW, Australia
Official's Role
Principal Investigator
Facility Information:
Facility Name
Dept. of Intensive Care, Nepean Hosp., U Sydney
City
Penrith
State/Province
New South Wales
ZIP/Postal Code
2751
Country
Australia
12. IPD Sharing Statement
Citations:
PubMed Identifier
24666826
Citation
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.
Results Reference
derived
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0.5M Na Lactate Solution in Acute Heart Failure (AHF)
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