Trial Outcomes & Findings for A Comparison of Two Albumin Administration Schedules for Spontaneous Bacterial Peritonitis (NCT NCT02528097)

Results Overview

Primary outcome is the presence of renal failure at any point from the start of the study (time 0) through 72 hours

Recruitment status

TERMINATED

Study phase

NA

Target enrollment

2 participants

Primary outcome timeframe

At any point from time 0 through day 3

Results posted on

2016-07-11

Participant Flow

Participant milestones

Participant milestones
Measure	Active Comparator Standard Care albumin administered day 1 (1.5g/kg) and day 3 (1.0g/kg) Standard Care: Standard Care: 25% salt poor albumin administered day 1 (1.5g/kg) and day 3 (1.0g/kg)	Experimental Albumin administered per standard care on day 1 (1.5g/kg). Second dose administered on day 2 only to those individuals with renal insufficiency and risk for renal failure (Cr \> 1.0 or BUN or Cr \> baseline). If albumin not administered at 48 hours, BUN and Cr will be monitored daily for 72 hours and will be administered if Cr \> 1.0 or BUN or Cr are above baseline. Experimental: 25% salt poor albumin administered per standard care on day 1 (1.5g/kg). Second dose administered on day 2 or later only to those individuals with renal insufficiency and risk for renal failure (Cr \> 1.0 or BUN or Cr \> baseline)
Overall Study STARTED	1	1
Overall Study COMPLETED	1	1
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

A Comparison of Two Albumin Administration Schedules for Spontaneous Bacterial Peritonitis

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Active Comparator Standard Care n=1 Participants albumin administered day 1 (1.5g/kg) and day 3 (1.0g/kg) Standard Care: Standard Care: 25% salt poor albumin administered day 1 (1.5g/kg) and day 3 (1.0g/kg)	Experimental n=1 Participants Albumin administered per standard care on day 1 (1.5g/kg). Second dose administered on day 2 only to those individuals with renal insufficiency and risk for renal failure (Cr \> 1.0 or BUN or Cr \> baseline). If albumin not administered at 48 hours, BUN and Cr will be monitored daily for 72 hours and will be administered if Cr \> 1.0 or BUN or Cr are above baseline. Experimental: 25% salt poor albumin administered per standard care on day 1 (1.5g/kg). Second dose administered on day 2 or later only to those individuals with renal insufficiency and risk for renal failure (Cr \> 1.0 or BUN or Cr \> baseline)	Total n=2 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	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Sex: Female, Male Female	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Sex: Female, Male Male	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants

PRIMARY outcome

Timeframe: At any point from time 0 through day 3

Population: Outcome data was not collected due to logistical challenges of completing the study.

Primary outcome is the presence of renal failure at any point from the start of the study (time 0) through 72 hours

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: At any point from time 0 through day 3

Population: Outcome data was not collected due to logistical challenges of completing the study.

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: Throughout Study (72 hours)

The amount of albumin administered to each study participant over the course of the study (time 0 through 72 hours)

Outcome measures

Outcome data not reported

Adverse Events

Active Comparator Standard Care

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Experimental

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

The Office of Clinical Trials

NYU Langone Medical Center

Phone: 646.754.7431

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place