0.5M Na Lactate Solution in Acute Heart Failure (AHF)

• Status: Completed
• Trial end date: 2013-08-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Nepean Blue Mountains Local Health District
• Collaborator: Innogene Kalbiotech Pte. Ltd
• Treatments: Pharmaceutical Solutions

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