Trial Outcomes & Findings for Furosemide and Albumin for Diuresis of Edema: A Pilot Randomized Controlled Trial (NCT NCT02055872)

Results Overview

Ventilator-free days

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

46 participants

Primary outcome timeframe

30 days

Results posted on

2024-03-25

Participant Flow

Participant milestones

Participant milestones
Measure	Intravenous Albumin (n=24) Administration of 25% albumin by intravenous infusion, twice daily for a total of 72 hours (6 treatments) Intravenous albumin	Normal Saline (n=21) Administration of 100 mL normal saline by intravenous infusion, twice daily, for 72 hours (6 treatments) Normal saline
Overall Study STARTED	24	21
Overall Study COMPLETED	24	21
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Intravenous Albumin (n=24) n=24 Participants Administration of 25% albumin by intravenous infusion, twice daily for a total of 72 hours (6 treatments) Intravenous albumin	Normal Saline (n=21) n=21 Participants Administration of 100 mL normal saline by intravenous infusion, twice daily, for 72 hours (6 treatments) Normal saline	Total n=45 Participants Total of all reporting groups
Age, Continuous	61.71 years STANDARD_DEVIATION 17.2 • n=24 Participants	64.7 years STANDARD_DEVIATION 15.2 • n=21 Participants	63.1 years STANDARD_DEVIATION 23 • n=45 Participants
Sex: Female, Male Female	11 Participants n=24 Participants	5 Participants n=21 Participants	16 Participants n=45 Participants
Sex: Female, Male Male	13 Participants n=24 Participants	16 Participants n=21 Participants	29 Participants n=45 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.

PRIMARY outcome

Timeframe: 30 days

Ventilator-free days

Outcome measures

Outcome measures
Measure	Intravenous Albumin (n=24) n=24 Participants Administration of 25% albumin by intravenous infusion, twice daily for a total of 72 hours (6 treatments) Intravenous albumin	Normal Saline (n=21) n=21 Participants Administration of 100 mL normal saline by intravenous infusion, twice daily, for 72 hours (6 treatments) Normal saline
Ventilator-free Days	4 days Interval 0.0 to 23.5	13 days Interval 0.0 to 21.0

SECONDARY outcome

Timeframe: Day 1, Day 3, Day 5

Changes in serum albumin and serum colloid osmotic pressure measurements from Day 1, Day 3, Day 5

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 30 days

Total ICU mortality and mortality at 30 days.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Day 1, Day 3, Day 5

Change in total fluid balance and body weight from baseline at 3 days and 5 days

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Day 1, Day 3, Day 5

Changes in oxygenation (FiO2, P/F ratio, oxygenation index) from baseline at day 3 and day 5

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Day 1, Day 2, Day 3

Number of episodes of interrupting treatment with furosemide (eg. hypotensive episodes, renal failure, contraction alkalosis, etc.)

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 30 days

Total duration of mechanical ventilation

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Study end

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: Day 1

The administration of at least the first dose of study treatment (albumin or placebo) within two hours of the first administration of furosemide

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: Day 3

Patients receiving full 72 hours (6 doses) of study treatment

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: Day 3

Absence of hyperoncotic albumin administration to patients randomized to the control arm

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: Study duration

1. Randomization rate of patients eligible by screening criteria 2. Randomization rate of patients eligible by clinical site

Outcome measures

Outcome data not reported

Adverse Events

Intravenous Albumin (n=24)

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Normal Saline (n=21)

Serious events: 0 serious events

Other events: 4 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Intravenous Albumin (n=24) n=24 participants at risk Administration of 25% albumin by intravenous infusion, twice daily for a total of 72 hours (6 treatments) Intravenous albumin	Normal Saline (n=21) n=21 participants at risk Administration of 100 mL normal saline by intravenous infusion, twice daily, for 72 hours (6 treatments) Normal saline
Cardiac disorders Hypotension	8.3% 2/24 • Number of events 2	19.0% 4/21 • Number of events 4

Additional Information

Simon Oczkowski

McMaster University

Phone: 905 521 2100

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place