Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01981655
Other study ID # SOLACE1
Secondary ID
Status Completed
Phase Phase 2
First received August 13, 2013
Last updated November 9, 2013
Start date December 2009
Est. completion date August 2013

Study information

Verified date November 2013
Source Nepean Blue Mountains Local Health District
Contact n/a
Is FDA regulated No
Health authority Australia: Human Research Ethics Committee
Study type Interventional

Clinical 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. 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.


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).


Recruitment information / eligibility

Status Completed
Enrollment 41
Est. completion date August 2013
Est. primary completion date February 2013
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Outcomes Assessor), Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Drug:
0.5M Sodium lactate
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 solution
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

Locations

Country Name City State
Australia Dept. of Intensive Care, Nepean Hosp., U Sydney Penrith New South Wales

Sponsors (2)

Lead Sponsor Collaborator
Nepean Blue Mountains Local Health District Innogene Kalbiotech Pte. Ltd

Country where clinical trial is conducted

Australia, 

Outcome

Type Measure Description Time frame Safety issue
Primary Efficacy Improvement in cardiac output measured by transthoracic echocardiography at 24 hours from initiation of study drug infusion Baseline till 24 hours from first loading of study drug Yes
Secondary mortality range of efficacy and safety parameters up to 3 month Yes
Secondary 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 48 hours Yes
Secondary 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 48 hours Yes
See also
  Status Clinical Trial Phase
Terminated NCT02151383 - Pharmacokinetics & Safety of Serelaxin on Top of Standard of Care Therapy in Pediatric Patients With Acute Heart Failure Phase 2
Completed NCT02135835 - A Study to Evaluate the Efficacy and Safety of Shenfu Zhusheye in Patients With Acute Heart Failure Phase 4
Recruiting NCT05556044 - Empagliflozin for New On-set Heart Failure Study Regardless of Ejection Fraction Phase 3
Recruiting NCT04363697 - Dapagliflozin and Effect on Cardiovascular Events in Acute Heart Failure -Thrombolysis in Myocardial Infarction 68 (DAPA ACT HF-TIMI 68) Phase 4
Completed NCT02122640 - Evaluation of Acute Cardiogenic Dyspnoea With Thorax Echography and Pro-BNP in the Emergency Department N/A
Completed NCT01193998 - Impact of Validated Diagnostic Prediction Model of Acute Heart Failure in the Emergency Department N/A
Not yet recruiting NCT01211886 - Utility of Brain Natriuretic Peptide (BNP) in Patients With Type IV Cardio-renal Syndrome Admitted to the Intensive Care Unit (ICU) N/A
Not yet recruiting NCT06465498 - Investigating aCute heArt failuRe Decongestion Guided by Lung UltraSonography N/A
Recruiting NCT05276219 - Optimized Treatment of Pulmonary Edema or Congestion Phase 4
Recruiting NCT05392764 - Early Treatment With a Sodium-glucose Co-transporter 2 Inhibitor in High-risk Patients With Acute Heart Failure Phase 3
Recruiting NCT03157219 - Manipal Heart Failure Registry (MHFR) N/A
Completed NCT06024889 - Acute Effects of Furosemide on Hemodynamics and Pulmonary Congestion in Acute Decompensated Heart Failure. Phase 1/Phase 2
Terminated NCT04174794 - Investigating Reduction of aCute heArt Failure Readmission With Lung UltraSound-preliminary Trial
Recruiting NCT05972746 - Telemonitoring Program in the Vulnerable Phase After Hospitalization for Heart Failure N/A
Enrolling by invitation NCT02258984 - Can the Venus 1000 Help Clinicians Treat Patients With Severe Sepsis or Acute Heart Failure? The CVP Trial N/A
Completed NCT02141607 - Evolution of Molecular Biomarkers in Acute Heart Failure Induced by Shock
Completed NCT01870778 - Efficacy, Safety and Tolerability of Serelaxin When Added to Standard Therapy in AHF Phase 3
Recruiting NCT05986773 - Diuretic Strategies in Acute Heart Failure Patients at High Risk for Diuretic Resistance Phase 4
Recruiting NCT04163588 - Sequential Nephron Blockade in Acute Heart Failure Phase 3
Recruiting NCT03720288 - Acetazolamide in Patients With Acute Heart Failure Phase 3