0.5M Na Lactate Solution in Acute Heart Failure (AHF) (NCT01981655) | Clinical Trial Compass
CompletedPhase 2
0.5M Na Lactate Solution in Acute Heart Failure (AHF)
Australia41 participantsStarted 2009-12
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Efficacy
Timeframe: Baseline till 24 hours from first loading of study drug
Trial details
NCT IDNCT01981655
SponsorNepean Blue Mountains Local Health District