Trial Outcomes & Findings for Clinical, Inflammatory, and Economic Impact of Dextran 70 in Treating Spontaneous Bacterial Peritonitis (NCT NCT00570960)

NCT ID: NCT00570960

Last Updated: 2014-12-03

Results Overview

30 day all cause mortality

• Recruitment status: TERMINATED
• Study phase: PHASE4
• Target enrollment: 8 participants
• Primary outcome timeframe: 30 days
• Results posted on: 2014-12-03

Participant Flow

Hospitalized cirrhosis patients with SBP between September 2007 and July 2009

Participant milestones

Measure	Dextran Therapy Arm antibiotic therapy in addition to dextran 70, 1.0 g/kg on days one, two and three Dextran 70 : dextran 70, 1.0 g/kg on days one, two and three	Standard of Care Albumin Arm antibiotic therapy in addition to human albumin, 1.5 g/kg on day one and 1.0 g/kg on day three human albumin : human albumin 1.5 g/kg on day one and 1.0 g/kg on day three
Overall Study STARTED	4	4
Overall Study COMPLETED	4	4
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Clinical, Inflammatory, and Economic Impact of Dextran 70 in Treating Spontaneous Bacterial Peritonitis

Baseline characteristics by cohort

Measure	Dextran Therapy Arm n=4 Participants antibiotic therapy in addition to dextran 70, 1.0 g/kg on days one, two and three Dextran 70 : dextran 70, 1.0 g/kg on days one, two and three	Standard of Care Albumin Arm n=4 Participants antibiotic therapy in addition to human albumin, 1.5 g/kg on day one and 1.0 g/kg on day three human albumin : human albumin 1.5 g/kg on day one and 1.0 g/kg on day three	Total n=8 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	4 Participants n=5 Participants	3 Participants n=7 Participants	7 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Age, Continuous	51.5 years STANDARD_DEVIATION 7.0 • n=5 Participants	51.8 years STANDARD_DEVIATION 12.2 • n=7 Participants	51.6 years STANDARD_DEVIATION 9.2 • n=5 Participants
Sex: Female, Male Female	2 Participants n=5 Participants	1 Participants n=7 Participants	3 Participants n=5 Participants
Sex: Female, Male Male	2 Participants n=5 Participants	3 Participants n=7 Participants	5 Participants n=5 Participants
Region of Enrollment United States	4 participants n=5 Participants	4 participants n=7 Participants	8 participants n=5 Participants

PRIMARY outcome

Timeframe: 30 days

30 day all cause mortality

Outcome measures

Measure	Dextran Therapy Arm n=4 Participants antibiotic therapy in addition to dextran 70, 1.0 g/kg on days one, two and three Dextran 70 : dextran 70, 1.0 g/kg on days one, two and three	Standard of Care Albumin Arm n=4 Participants antibiotic therapy in addition to human albumin, 1.5 g/kg on day one and 1.0 g/kg on day three human albumin : human albumin 1.5 g/kg on day one and 1.0 g/kg on day three
30 Day All Cause Mortality	1 participants	2 participants

Adverse Events

Dextran Therapy Arm

Serious events: 0 serious events

Other events: 4 other events

Deaths: 0 deaths

Standard of Care Albumin Arm

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Dextran Therapy Arm n=4 participants at risk antibiotic therapy in addition to dextran 70, 1.0 g/kg on days one, two and three Dextran 70 : dextran 70, 1.0 g/kg on days one, two and three	Standard of Care Albumin Arm n=4 participants at risk antibiotic therapy in addition to human albumin, 1.5 g/kg on day one and 1.0 g/kg on day three human albumin : human albumin 1.5 g/kg on day one and 1.0 g/kg on day three
Musculoskeletal and connective tissue disorders Muscle cramps	25.0% 1/4 • Number of events 1 • Within 30 days of study drug administration.	0.00% 0/4 • Within 30 days of study drug administration.
Infections and infestations Fever	25.0% 1/4 • Number of events 1 • Within 30 days of study drug administration.	25.0% 1/4 • Number of events 1 • Within 30 days of study drug administration.
Nervous system disorders Hepatic Encephalopathy	0.00% 0/4 • Within 30 days of study drug administration.	25.0% 1/4 • Number of events 2 • Within 30 days of study drug administration.
Gastrointestinal disorders Clostridium difficle colitis	25.0% 1/4 • Number of events 1 • Within 30 days of study drug administration.	0.00% 0/4 • Within 30 days of study drug administration.
Hepatobiliary disorders Excess ascites recurrence	25.0% 1/4 • Number of events 1 • Within 30 days of study drug administration.	25.0% 1/4 • Number of events 1 • Within 30 days of study drug administration.

Additional Information

Patrick G. Northup, M.D.

University of Virginia

Phone: 434-924-0000

Email: northup@virginia.edu

Results disclosure agreements

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