Acute Heart FailurePhase 2SOLACE1NCT01981655
0.5M Na Lactate Solution in Acute Heart Failure (AHF)
A Phase 2 study testing 0.5M Sodium lactate and Hartmann's solution in people with Acute Heart Failure, run by Nepean Blue Mountains Local Health District at 1 site in Australia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Heart Failure
- What is being tested?
- 0.5M Sodium lactate and Hartmann's solution
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 41 participants
- Where
- 1 siteAustralia
- Study dates
- Dec 2009to Aug 2013
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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.
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
Australia1 site
Dept. of Intensive Care, Nepean Hosp., U Sydney
Penrith, New South Wales, 2751
About this study
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
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:
Read more
- 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.
- To assess effects of 0.5M Na lactate (Totilac) on plasma and urine biological parameters (sodium, potassium, chloride, pH, bicarb, base excess, albumin)
- To assess effects of 0.5M Na lactate on morbidity and mortality.
Read the 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).
- Conditions
- Acute Heart Failure
- Being tested
- 0.5M Sodium lactate, Hartmann's solution
- Keywords
- Sodium Lactate, Acute, Heart, Failure, Perfusion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
0.5M Sodium lactateDrug
Also called Totilac
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
Hartmann's solutionDrug
Also called Compound Sodium Lactate
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
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: Drug: Hartmann's solution |
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy
Improvement in cardiac output measured by transthoracic echocardiography at 24 hours from initiation of study drug infusion
Measured: Baseline till 24 hours from first loading of study drug
Secondary outcomes (3)
mortality
range of efficacy and safety parameters
Measured: up to 3 month
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
Measured: 48 hours
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
Measured: 48 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Nov 2013 (estimated)
- Study startDec 2009
- Primary completionFeb 2013
- Study completionAug 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Acute Heart FailureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 41 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nepean Blue Mountains Local Health District
- Sponsor type
- University, hospital or other
- Collaborators
- Innogene Kalbiotech Pte. Ltd
- Responsible party
- Principal investigator, Marek Nalos, Nepean Blue Mountains Local Health District
- Investigators
- Marek Nalos, MD, Principal investigator, Dept. of Intensive Care, Nepean Hosp., U Sydney, Penrith, NSW, Australia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01981655
- Sponsor's protocol ID
- SOLACE1
- Acronym
- SOLACE1
- Status last verified
- Nov 2013
- First submitted
- 13 Aug 2013
- Last updated
- 13 Nov 2013
- Results posted
- No
- Data monitoring committee
- Yes
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.
PubMed 24666826
Study at a glance
From the registry record, last updated by the sponsor on 13 Nov 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01981655
- Acronym / sponsor ID
- SOLACE1 / SOLACE1
- Conditions
- Acute Heart Failure
- Keywords
- Sodium Lactate, Acute, Heart, Failure, Perfusion
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 41 participants (actual)
- Lead sponsor
- Nepean Blue Mountains Local Health DistrictUniversity, hospital or other
- Collaborators
- Innogene Kalbiotech Pte. Ltd
- Study start
- Dec 2009
- Primary completion
- Feb 2013 (actual)
- Study completion
- Aug 2013 (actual)
- First posted
- 11 Nov 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
- To assess effects of 0.5M Na lactate (Totilac) on plasma and urine biological parameters (sodium, potassium, chloride, pH, bicarb, base excess, albumin)
- 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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 0.5M Sodium lactate | Experimental | Drug: 0.5M Sodium lactateA 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 | Active comparator | Drug: Hartmann's solutionHartmann'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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Age: more than 18 years
- Heart failure criteria:
- 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
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 0.5M Sodium lactateAlso: TotilacA 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 | Drug | 0.5M Sodium lactate |
| Hartmann's solutionAlso: Compound Sodium LactateHartmann'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 | Drug | Hartmann's solution |
Primary outcome
Efficacy
Time frame: Baseline till 24 hours from first loading of study drug
Improvement in cardiac output measured by transthoracic echocardiography at 24 hours from initiation of study drug infusion
3 secondary outcomes
mortality
Time frame: up to 3 month
acid base and electrolytes, fluid balance
Time frame: 48 hours
organ function
Time frame: 48 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Nov 2013.
- Derived from this study: PubMed 24666826Nalos 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marek Nalos, MD principal investigator
Dept. of Intensive Care, Nepean Hosp., U Sydney, Penrith, NSW, Australia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing 0.5M Sodium lactate and Hartmann's solution in people with Acute Heart Failure, run by Nepean Blue Mountains Local Health District at 1 site in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Nov 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Efficacy (time frame: Baseline till 24 hours from first loading of study drug). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01981655, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Nov 2013.