Trial Outcomes & Findings for Loop Diuretics Administration and Acute Heart Failure (NCT NCT01441245)

NCT ID: NCT01441245

Last Updated: 2018-01-23

Results Overview

this study aimed to evaluate the effects of continuous infusion of furosemide in comparison to twice daily regimens at similar doses with respect to changes in renal function in terms of creatinine levels and GFR, urine output and BNP levels from admission to discharge

• Recruitment status: COMPLETED
• Study phase: PHASE4
• Target enrollment: 57 participants
• Primary outcome timeframe: time period ranging from 72 h to 120 h.
• Results posted on: 2018-01-23

Participant Flow

Department of Internal Medicine, Cardiology Section Centre into a Para-Intensive Unit (Siena, Italy) from April 2011 to December 2012.

22 were excluded because of normal renal function at baseline, 11 for receiving different dosages of intravenous furosemide, 4 for isolated diastolic HF

Participant milestones

Measure	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.
Overall Study STARTED	30	27
Overall Study COMPLETED	30	27
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Loop Diuretics Administration and Acute Heart Failure

Baseline characteristics by cohort

Measure	cIV Group n=30 Participants The group that received the continuous infusion of furosemide (cIV), consisted of 30 patients.	iIV Group n=27 Participants The group that received the intermittent infusion of furosemide (iIV), consisted of 27 patients.	Total n=57 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	5 Participants n=5 Participants	6 Participants n=7 Participants	11 Participants n=5 Participants
Age, Categorical >=65 years	25 Participants n=5 Participants	21 Participants n=7 Participants	46 Participants n=5 Participants
Age, Continuous	71 years STANDARD_DEVIATION 7 • n=5 Participants	73 years STANDARD_DEVIATION 8 • n=7 Participants	72 years STANDARD_DEVIATION 8 • n=5 Participants
Sex: Female, Male Female	14 Participants n=5 Participants	13 Participants n=7 Participants	27 Participants n=5 Participants
Sex: Female, Male Male	16 Participants n=5 Participants	14 Participants n=7 Participants	30 Participants n=5 Participants
Region of Enrollment Italy	30 participants n=5 Participants	27 participants n=7 Participants	57 participants n=5 Participants

PRIMARY outcome

Timeframe: time period ranging from 72 h to 120 h.

this study aimed to evaluate the effects of continuous infusion of furosemide in comparison to twice daily regimens at similar doses with respect to changes in renal function in terms of creatinine levels and GFR, urine output and BNP levels from admission to discharge

Outcome measures

Measure	Urine Output in cIV n=30 Participants Evaluation of urine output in Intermittent intravenous furosemide infusion group	Urine Output in iIV n=27 Participants Evaluation of urine output in Intermittent intravenous furosemide infusion group
Evaluation of Mean Urine Output Volume During the Infusion Period	2505 mL Standard Deviation 796	2140 mL Standard Deviation 468

PRIMARY outcome

Timeframe: from admission to discharge, an average of 12 days

Population: All data were analyzed with intention-to-treat. Continuous variables are expressed as mean ± standard deviation (SD) and compared with t test for independent groups. p values \<0.05 were considered significant.

Outcome measures

Measure	Urine Output in cIV n=30 Participants Evaluation of urine output in Intermittent intravenous furosemide infusion group	Urine Output in iIV n=27 Participants Evaluation of urine output in Intermittent intravenous furosemide infusion group
Evaluation of Renal Function in Terms of Creatinine Levels at Discharge	1.78 mg/dL Standard Deviation 0.5	1.51 mg/dL Standard Deviation 0.3

PRIMARY outcome

Timeframe: participants were followed for the duration of hospital stay, an average of 13 days

Population: All data were analyzed with intention-to-treat. Continuous variables are expressed as mean ± standard deviation (SD) and compared with t test for independent groups. p values \<0.05 were considered significant.

evaluation of renal function in terms of changes in creatinine levels during hospitalization in the two arms.

Outcome measures

Measure	Urine Output in cIV n=30 Participants Evaluation of urine output in Intermittent intravenous furosemide infusion group	Urine Output in iIV n=27 Participants Evaluation of urine output in Intermittent intravenous furosemide infusion group
Evaluation of Renal Function in Terms of Changes in Creatinine Levels	-0.10 mg/dL Standard Deviation 0.30	-0.50 mg/dL Standard Deviation 0.34

PRIMARY outcome

Timeframe: from admission to discharge, an average of 12 days

Outcome measures

Measure	Urine Output in cIV n=30 Participants Evaluation of urine output in Intermittent intravenous furosemide infusion group	Urine Output in iIV n=27 Participants Evaluation of urine output in Intermittent intravenous furosemide infusion group
Evaluation of B-type Natriuretic Peptide (BNP) Levels From Admission to the End of Treatment	679 pg/ml Standard Deviation 397	949 pg/ml Standard Deviation 548

PRIMARY outcome

Timeframe: participants were followed for the duration of hospital stay, an average of 13 days

Population: Continuous variables are expressed as mean ± standard deviation (SD) and compared with t test for independent groups. p values \<0.05 were considered significant.

Outcome measures

Measure	Urine Output in cIV n=30 Participants Evaluation of urine output in Intermittent intravenous furosemide infusion group	Urine Output in iIV n=27 Participants Evaluation of urine output in Intermittent intravenous furosemide infusion group
Change in Brain Natriuretic Peptide (BNP) Levels From Admission to the Discharge	-525 pg/mL Standard Deviation 615	-148 pg/mL Standard Deviation 463

PRIMARY outcome

Timeframe: from admission to discharge, an average of 12 days

Outcome measures

Measure	Urine Output in cIV n=30 Participants Evaluation of urine output in Intermittent intravenous furosemide infusion group	Urine Output in iIV n=27 Participants Evaluation of urine output in Intermittent intravenous furosemide infusion group
Evaluation of Renal Function in Terms of Changes in GFR	-3.18 (ml/min·1.73 m2) Standard Deviation 2.45	-1.93 (ml/min·1.73 m2) Standard Deviation 2.90

PRIMARY outcome

Timeframe: from admission to discharge, an average of 12 days

Population: Continuous variables are expressed as mean ± standard deviation (SD) and compared with t test for independent groups. p values \<0.05 were considered significant

Outcome measures

Measure	Urine Output in cIV n=30 Participants Evaluation of urine output in Intermittent intravenous furosemide infusion group	Urine Output in iIV n=27 Participants Evaluation of urine output in Intermittent intravenous furosemide infusion group
Evaluation of Renal Function in Terms of GFR Values at Discharge	44.8 (ml/min·1.73 m2) Standard Deviation 6.1	46.7 (ml/min·1.73 m2) Standard Deviation 6.1

SECONDARY outcome

Timeframe: in-hospital

Population: Qualitative variables are expressed as percentage and compared with chi-square test . p values \<0.05 were considered significant.

percentage of participants with hospital stay > 10 days

Outcome measures

Measure	Urine Output in cIV n=30 Participants Evaluation of urine output in Intermittent intravenous furosemide infusion group	Urine Output in iIV n=27 Participants Evaluation of urine output in Intermittent intravenous furosemide infusion group
Length of Hospitalization in the Two Groups	80 percentage of partecipants	44 percentage of partecipants

SECONDARY outcome

Timeframe: in-hospital

Outcome measures

Measure	Urine Output in cIV n=30 Participants Evaluation of urine output in Intermittent intravenous furosemide infusion group	Urine Output in iIV n=27 Participants Evaluation of urine output in Intermittent intravenous furosemide infusion group
Dopamine Infusion During Hospitalization	50 percentage of partecipants	26 percentage of partecipants

Adverse Events

cIV Group

Serious events: 14 serious events

Other events: 0 other events

Deaths: 0 deaths

iIV Group

Serious events: 9 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Measure	cIV Group n=30 participants at risk The group that received the continuous infusion of furosemide (cIV), consisted of 30 patients.	iIV Group n=27 participants at risk The second group that received the same drug in bolus injections twice a day (iIV), consisted of 27 patients.
Cardiac disorders death	20.0% 6/30 • Number of events 6 • The 6-months follow-up events encompassed: cardiac death, rehospitalization for all cardiovascular causes, and severe renal insufficiency needing hemodialysis.	11.1% 3/27 • Number of events 3 • The 6-months follow-up events encompassed: cardiac death, rehospitalization for all cardiovascular causes, and severe renal insufficiency needing hemodialysis.
Cardiac disorders rehospitalization for all cardiovascular causes	26.7% 8/30 • Number of events 8 • The 6-months follow-up events encompassed: cardiac death, rehospitalization for all cardiovascular causes, and severe renal insufficiency needing hemodialysis.	22.2% 6/27 • Number of events 6 • The 6-months follow-up events encompassed: cardiac death, rehospitalization for all cardiovascular causes, and severe renal insufficiency needing hemodialysis.
Renal and urinary disorders needing renal replacement therapy	0.00% 0/30 • The 6-months follow-up events encompassed: cardiac death, rehospitalization for all cardiovascular causes, and severe renal insufficiency needing hemodialysis.	0.00% 0/27 • The 6-months follow-up events encompassed: cardiac death, rehospitalization for all cardiovascular causes, and severe renal insufficiency needing hemodialysis.

Other adverse events

Adverse event data not reported

Additional Information

Alberto Palazzuoli MD, Cardiology Unit

Department of Internal Medicine, University of Siena, Le Scotte hospital, Siena, Italy

Phone: +39577585363

Email: palazzuoli2@unisi.it

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place