Hypertonic Saline Solution in Heart Failure

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

34 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-02-29

Study Completion Date

2010-12-31

Brief Summary

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Patients with decompensated heart failure have high rates of mortality and morbidity despite recent improvements in diagnosis and treatment. Some aspects of their presentation such as renal failure, hyponatremia and congestive phenomena have received special attention, as they are associated with worse prognosis. The infusion of hypertonic saline solution has been tested in different conditions of cardiovascular collapse. Current evidence indicates that the infusion of hypertonic solution in heart failure patients can provide clinical and haemodynamic improvement. The investigators are testing the hypothesis that the infusion of hypertonic solution in association with diuretics may prevent the occurrence of renal dysfunction in patients with decompensated heart failure.

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Detailed Description

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Conditions

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Heart Failure Renal Failure Hyponatremia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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A

Group of patients that will receive hypertonic saline solution (NaCl 7,5%)

Group Type ACTIVE_COMPARATOR

NaCl 7,5% (Hypertonic Saline Solution)

Intervention Type DRUG

Patients in the intervention arm will receive 100ml of NaCl 7,5, twice daily during 3 days

B

Group of patients that will receive placebo

Group Type PLACEBO_COMPARATOR

NaCl 0,9%

Intervention Type DRUG

Patients in the placebo arm will receive 100ml of NaCl 0,9% twice daily during 3 days

Interventions

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NaCl 7,5% (Hypertonic Saline Solution)

Patients in the intervention arm will receive 100ml of NaCl 7,5, twice daily during 3 days

Intervention Type DRUG

NaCl 0,9%

Patients in the placebo arm will receive 100ml of NaCl 0,9% twice daily during 3 days

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Age over 18 years old
* Heart failure according to Framingham criteria
* Episode of acute decompensation,with need of in-hospital treatment
* Presence of congestive phenomena

Exclusion Criteria

* Patient denial
* Left-ventricle ejection fraction over 0,4, as measure by transthoracic echocardiography
* Rheumatic disease
* Restrictive cardiomyopathy
* Alcohol abuse
* Chronic obstructive pulmonary disease
* Cancer
* Pulmonary embolism during the last 6 months
* Surgical procedures or acute illness during the last 30 days
* Chronic or acute infection
* Any other circumstance that may hamper patient prognosis for the next 6 months
* Serum creatine over 3.0mg/dL
* Serum potassium over 5.5 mEqs/L
* Any specific condition associated to the acute episode of decompensation, such as new onset cardiac arrhythmias, heart ischemia, infection, etc.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No