Fluid and Salt Restriction in Decompensated Heart Failure Patients
|ClinicalTrials.gov Identifier: NCT01133236|
Recruitment Status : Completed
First Posted : May 28, 2010
Last Update Posted : January 3, 2014
|Condition or disease||Intervention/treatment||Phase|
|Heart Failure||Dietary Supplement: Salt and fluid restriction||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||80 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Official Title:||Randomized Clinical Trial to Assess the Effect of Fluid and Salt Restriction on the Management of Patients Hospitalized Due to Decompensated Heart Failure|
|Study Start Date :||August 2009|
|Actual Primary Completion Date :||September 2012|
|Actual Study Completion Date :||September 2012|
Experimental: Salt and Fluid
Intervention: Fluid 800 Ml and Salt 2 g per day Control: FLuid and Salt Free
Dietary Supplement: Salt and fluid restriction
I: Intervention Prescription of low-sodium diet with additional 2 g of sodium and water restriction to 800 mL/day.
II: Control Prescription without sodium and fluid restriction.
- Bodyweight loss [ Time Frame: 7 days ]Daily weight on a digital scale
- Clinical stability [ Time Frame: Seven days. ]Clinical assessment daily for 7 days.
- Health state evaluation. [ Time Frame: 30 days ]Evaluation of health state using the Euro-QOL 5D for 30 days after the 7th day of clinical stability assessment.
- Evaluation of thirst sensation. [ Time Frame: Seven days ]Evaluation of thirst score on the Thirst Scale, daily for seven days.
- Re-hospitalizations. [ Time Frame: 30 days ]Medical records assessed for 30 days after the 7th day of clinical stability assessment.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01133236
|Principal Investigator:||Luis B Silva-Neto, MD, ScD||Post Graduated Program of Federal University Program|