Trial Outcomes & Findings for Effect of Acetazolamide and Furosemide on Obesity-induced Glomerular Hyperfiltration (NCT NCT01146288)

NCT ID: NCT01146288

Last Updated: 2015-06-04

Results Overview

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 13 participants
• Primary outcome timeframe: baseline and after diuretics administration
• Results posted on: 2015-06-04

Participant Flow

Participants recruited between July 2010 and October 2012.

19 screened, 6 excluded (2 did not meet inclusion criteria, 2 refused participation, 2 unable to adequately collect urine).

Participant milestones

Measure	Acetazolamide First, Then Furosemide Intravenous acetazolamide 5 mg/kg/5 min. in first intervention period and intravenous furosemide 2 mg/5min in second intervention period (after washout period).	Furosemide First , Than Acetazolamide Intravenous furosemide 2 mg/5min in first intervention period and intravenous acetazolamide 5 mg/kg/5 min. in second intervention period (after washout period).
First Intervention(1 Day) STARTED	7	6
First Intervention(1 Day) COMPLETED	7	5
First Intervention(1 Day) NOT COMPLETED	0	1
Second Intervention (1 Day) STARTED	7	5
Second Intervention (1 Day) COMPLETED	7	5
Second Intervention (1 Day) NOT COMPLETED	0	0

Reasons for withdrawal

Measure	Acetazolamide First, Then Furosemide Intravenous acetazolamide 5 mg/kg/5 min. in first intervention period and intravenous furosemide 2 mg/5min in second intervention period (after washout period).	Furosemide First , Than Acetazolamide Intravenous furosemide 2 mg/5min in first intervention period and intravenous acetazolamide 5 mg/kg/5 min. in second intervention period (after washout period).
First Intervention(1 Day) Adverse Event	0	1

Baseline Characteristics

Effect of Acetazolamide and Furosemide on Obesity-induced Glomerular Hyperfiltration

Baseline characteristics by cohort

Measure	Acetazolamide First, Then Furosemide n=7 Participants intravenous acetazolamide 5 mg/kg/5 min. in first intervention period, intravenous furosemide 2 mg/5min in second intervention period (after washout period).	Furosemide First, Then Acetazolamide n=5 Participants intravenous furosemide 2 mg/5min. in first intervention period, intravenous acetazolamide 5 mg/kg/5 min. in second intervention period (after washout period).	Total n=12 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	7 Participants n=5 Participants	5 Participants n=7 Participants	12 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Continuous	37 years STANDARD_DEVIATION 6.6 • n=5 Participants	36 years STANDARD_DEVIATION 7.1 • n=7 Participants	36 years STANDARD_DEVIATION 8 • n=5 Participants
Sex/Gender, Customized male	7 participants n=5 Participants	5 participants n=7 Participants	12 participants n=5 Participants

PRIMARY outcome

Timeframe: baseline and after diuretics administration

Outcome measures

Measure	Acetazolamide n=12 Participants intravenous acetazolamide 5 mg/kg/5 min.	Furosemide n=12 Participants intravenous furosemide 2 mg/5min.
Change in GFR (ml/Min) GFR before acetazolamide/furosemide administration	151 ml/min Standard Deviation 22	152 ml/min Standard Deviation 18
Change in GFR (ml/Min) GFR after acetazolamide/furosemide administration	120 ml/min Standard Deviation 16	150 ml/min Standard Deviation 28

PRIMARY outcome

Timeframe: baseline and after diuretics administration

Outcome measures

Measure	Acetazolamide n=12 Participants intravenous acetazolamide 5 mg/kg/5 min.	Furosemide n=12 Participants intravenous furosemide 2 mg/5min.
Renal Vascular Resistance (mm Hg/[ml/Min]) before acetazolamide/furosemide administration	0.078 mm Hg/[ml/min] Standard Deviation 1.017	0.073 mm Hg/[ml/min] Standard Deviation 0.010
Renal Vascular Resistance (mm Hg/[ml/Min]) after acetazolamide/furosemide administration	0.088 mm Hg/[ml/min] Standard Deviation 0.021	0.080 mm Hg/[ml/min] Standard Deviation 0.019

Adverse Events

Acetazolamide

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

Furosemide

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

P-aminohippuric Acid

Serious events: 1 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Measure	Acetazolamide n=12 participants at risk Intravenous acetazolamide 5 mg/kg/5 min.	Furosemide n=12 participants at risk Intravenous furosemide 2 mg/5min	P-aminohippuric Acid n=12 participants at risk；n=13 participants at risk Intravenous priming dose of p-aminohippuric acid (8 mg/kg) before diuretics administration
Skin and subcutaneous tissue disorders angioedema	— 0/0	— 0/0	7.7% 1/13 • Number of events 1

Other adverse events

Measure	Acetazolamide n=12 participants at risk Intravenous acetazolamide 5 mg/kg/5 min.	Furosemide n=12 participants at risk Intravenous furosemide 2 mg/5min	P-aminohippuric Acid n=12 participants at risk；n=13 participants at risk Intravenous priming dose of p-aminohippuric acid (8 mg/kg) before diuretics administration
General disorders hand paresthesia	16.7% 2/12 • Number of events 2	0.00% 0/12	0.00% 0/12
General disorders lip parestesia	8.3% 1/12 • Number of events 1	0.00% 0/12	0.00% 0/12
General disorders alteration of the sense of taste	8.3% 1/12 • Number of events 1	0.00% 0/12	0.00% 0/12

Additional Information

Dr Boris Zingerman

Rabin Medical Center

Email: borisz@clalit.org.il

Results disclosure agreements

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