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Trial record 1 of 4 for:    21366472 [PUBMED-IDS]
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Loop Diuretics Administration and Acute Heart Failure (diurHF)

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ClinicalTrials.gov Identifier: NCT01441245
Recruitment Status : Completed
First Posted : September 27, 2011
Results First Posted : February 2, 2016
Last Update Posted : January 23, 2018
Sponsor:
Information provided by (Responsible Party):
Alberto Palazzuoli MD PhD, University of Siena

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Condition: Acute Heart Failure
Intervention: Drug: furosemide infusion

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Department of Internal Medicine, Cardiology Section Centre into a Para-Intensive Unit (Siena, Italy) from April 2011 to December 2012.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
22 were excluded because of normal renal function at baseline, 11 for receiving different dosages of intravenous furosemide, 4 for isolated diastolic HF

Reporting Groups
  Description
cIV Group The group that received the continuous infusion of furosemide (cIV), consisted of 30 patients.
iIV Group The second group that received the same drug in bolus injections twice a day (iIV), consisted of 27 patients.

Participant Flow:   Overall Study
    cIV Group   iIV Group
STARTED   30   27 
COMPLETED   30   27 
NOT COMPLETED   0   0 



  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
cIV Group The group that received the continuous infusion of furosemide (cIV), consisted of 30 patients.
iIV Group The group that received the intermittent infusion of furosemide (iIV), consisted of 27 patients.
Total Total of all reporting groups

Baseline Measures
   cIV Group   iIV Group   Total 
Overall Participants Analyzed 
[Units: Participants]
 30   27   57 
Age 
[Units: Participants]
Count of Participants
     
<=18 years      0   0.0%      0   0.0%      0   0.0% 
Between 18 and 65 years      5  16.7%      6  22.2%      11  19.3% 
>=65 years      25  83.3%      21  77.8%      46  80.7% 
Age 
[Units: Years]
Mean (Standard Deviation)
 71  (7)   73  (8)   72  (8) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female      14  46.7%      13  48.1%      27  47.4% 
Male      16  53.3%      14  51.9%      30  52.6% 
Region of Enrollment 
[Units: Participants]
     
Italy   30   27   57 


  Outcome Measures

1.  Primary:   Evaluation of Mean Urine Output Volume During the Infusion Period   [ Time Frame: time period ranging from 72 h to 120 h. ]

2.  Primary:   Evaluation of Renal Function in Terms of Creatinine Levels at Discharge   [ Time Frame: from admission to discharge, an average of 12 days ]

3.  Primary:   Evaluation of Renal Function in Terms of Changes in Creatinine Levels   [ Time Frame: participants were followed for the duration of hospital stay, an average of 13 days ]

4.  Primary:   Evaluation of B-type Natriuretic Peptide (BNP) Levels From Admission to the End of Treatment   [ Time Frame: from admission to discharge, an average of 12 days ]

5.  Primary:   Change in Brain Natriuretic Peptide (BNP) Levels From Admission to the Discharge   [ Time Frame: participants were followed for the duration of hospital stay, an average of 13 days ]

6.  Primary:   Evaluation of Renal Function in Terms of Changes in GFR   [ Time Frame: from admission to discharge, an average of 12 days ]

7.  Primary:   Evaluation of Renal Function in Terms of GFR Values at Discharge   [ Time Frame: from admission to discharge, an average of 12 days ]

8.  Secondary:   Length of Hospitalization in the Two Groups   [ Time Frame: in-hospital ]

9.  Secondary:   Dopamine Infusion During Hospitalization   [ Time Frame: in-hospital ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
Our study didn't explain the reasons of renal dysfunction during treatment. Concurrent evaluation of BUN could further clarify the primary defect.The multivariate analysis could be inadequate for small sample; we intend to continue enrollment.


  More Information

Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Alberto Palazzuoli MD, Cardiology Unit
Organization: Department of Internal Medicine, University of Siena, Le Scotte hospital, Siena, Italy
phone: +39577585363
e-mail: palazzuoli2@unisi.it


Publications of Results:
Other Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Alberto Palazzuoli MD PhD, University of Siena
ClinicalTrials.gov Identifier: NCT01441245     History of Changes
Other Study ID Numbers: diuretic1
First Submitted: September 22, 2011
First Posted: September 27, 2011
Results First Submitted: January 26, 2015
Results First Posted: February 2, 2016
Last Update Posted: January 23, 2018