Trial Outcomes & Findings for Antibiotic Irrigation for Pancreatoduodenectomy (NCT NCT02186457)

NCT ID: NCT02186457

Last Updated: 2022-02-23

Results Overview

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 190 participants
• Primary outcome timeframe: 30 Days
• Results posted on: 2022-02-23

Participant Flow

more patients enrolled

Participant milestones

Measure	Polymyxin B in Normal Saline Polymyxin B (500,000 U) in 1 liter of 0.9% Normal Saline Polymyxin B in Normal Saline: Antibiotic irrigation via peritoneal lavage	Placebo: Normal Saline 0.9 % Normal Saline Placebo: Normal Saline: Placebo irrigation via peritoneal lavage
Overall Study STARTED	95	95
Overall Study COMPLETED	95	95
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Antibiotic Irrigation for Pancreatoduodenectomy

Baseline characteristics by cohort

Measure	Polymyxin B in Normal Saline n=95 Participants Polymyxin B (500,000 U) in 1 liter of 0.9% Normal Saline Polymyxin B in Normal Saline: Antibiotic irrigation via peritoneal lavage	Placebo: Normal Saline n=95 Participants 0.9 % Normal Saline Placebo: Normal Saline: Placebo irrigation via peritoneal lavage	Total n=190 Participants Total of all reporting groups
Age, Categorical Age distribution · <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Age distribution · Between 18 and 65 years	60 Participants n=5 Participants	55 Participants n=7 Participants	115 Participants n=5 Participants
Age, Categorical Age distribution · >=65 years	35 Participants n=5 Participants	40 Participants n=7 Participants	75 Participants n=5 Participants
Age, Continuous	63.7 years STANDARD_DEVIATION 1.3 • n=5 Participants	64.4 years STANDARD_DEVIATION 1.5 • n=7 Participants	64.1 years STANDARD_DEVIATION 1.4 • n=5 Participants
Sex: Female, Male Female	40 Participants n=5 Participants	38 Participants n=7 Participants	78 Participants n=5 Participants
Sex: Female, Male Male	55 Participants n=5 Participants	57 Participants n=7 Participants	112 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	1 Participants n=5 Participants	2 Participants n=7 Participants	3 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	1 Participants n=5 Participants	2 Participants n=7 Participants	3 Participants n=5 Participants
Race (NIH/OMB) White	90 Participants n=5 Participants	88 Participants n=7 Participants	178 Participants n=5 Participants
Race (NIH/OMB) More than one race	3 Participants n=5 Participants	2 Participants n=7 Participants	5 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Region of Enrollment United States	95 participants n=5 Participants	95 participants n=7 Participants	190 participants n=5 Participants

PRIMARY outcome

Timeframe: 30 Days

Outcome measures

Measure	Polymyxin B in Normal Saline n=95 Participants Polymyxin B (500,000 U) in 1 liter of 0.9% Normal Saline Polymyxin B in Normal Saline: Antibiotic irrigation via peritoneal lavage	Placebo: Normal Saline n=95 Participants 0.9 % Normal Saline Placebo: Normal Saline: Placebo irrigation via peritoneal lavage
The Number of Patients With Infections	11 Participants	10 Participants

SECONDARY outcome

Timeframe: 5 Days

Outcome measures

Measure	Polymyxin B in Normal Saline n=95 Participants Polymyxin B (500,000 U) in 1 liter of 0.9% Normal Saline Polymyxin B in Normal Saline: Antibiotic irrigation via peritoneal lavage	Placebo: Normal Saline n=95 Participants 0.9 % Normal Saline Placebo: Normal Saline: Placebo irrigation via peritoneal lavage
The Number of Patients With Fistulas	25 Participants	29 Participants

Adverse Events

Polymyxin B in Normal Saline

Serious events: 0 serious events

Other events: 0 other events

Deaths: 1 deaths

Placebo: Normal Saline

Serious events: 0 serious events

Other events: 0 other events

Deaths: 2 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Michael House

Indiana University School of Medicine

Phone: 3179440113

Email: michouse@iupui.edu

Results disclosure agreements

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