0.5M Na Lactate Solution in Acute Heart Failure (AHF) (SOLACE1)
Acute Heart Failure
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
Experimental
Active Comparator
0.5M Sodium lactate
Hartmann's solution
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