Trial Outcomes & Findings for Enteral Nutrition as Stress Ulcer Prophylaxis in Critically Ill Patients. (NCT NCT01477320)

Results Overview

1. Incidence of overt GI bleeding (as defined by the presence of coffee ground emesis, hematemesis of bright red blood, melena, or hematochezia) seen with Proton Pump Inhibitor (PPI) and EN versus EN alone in critically ill patients. 2. Incidence of significant GI bleeding, defined by a 3-point decrease in hematocrit within 24 hours accompanied by signs of overt GI bleeding, or by an unexplained 6-point decrease in hematocrit during any 48 hour period.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

124 participants

Primary outcome timeframe

Subjects will be followed from date of randomization until discharge from the ICU or cessation of Enteral Nutrition (EN) and successful initiation of oral feeds up to 100 weeks.

Results posted on

2018-01-16

Participant Flow

Recruitment started in July 2013 in the medical ICU of University of Louisville Hospital. In July 2014, a second recruitment site (medical ICU at Jewish Hospital) was added as a second site for recruitment.

Participant milestones

Participant milestones
Measure	Pantoprazole 40mg IV Daily and Tube Feed Pantoprazole 40 mg IV daily and tube feed.: Patients randomized to the control group "active Comparator" will receive tube feed plus an Pantoprazole 40 mg IV daily.	Placebo and Tube Feed. Placebo and tube feed: Patients randomized to Placebo group "placebo Comparator" will receive tube feed plus an Placebo.
Overall Study STARTED	62	62
Overall Study COMPLETED	55	47
Overall Study NOT COMPLETED	7	15

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

The patient excluded from analysis were extubated too soon after enrollment before starting tube feed

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Pantoprazole 40mg IV Daily and Tube Feed n=55 Participants Pantoprazole 40 mg IV daily and tube feed.: Patients randomized to the control group "active Comparator" will receive tube feed plus an Pantoprazole 40 mg IV daily.	Placebo and Tube Feed. n=47 Participants Placebo and tube feed: Patients randomized to Placebo group "placebo Comparator" will receive tube feed plus an Placebo.	Total n=102 Participants Total of all reporting groups
Age, Continuous	62 years n=93 Participants • The patient excluded from analysis were extubated too soon after enrollment before starting tube feed	58 years n=4 Participants • The patient excluded from analysis were extubated too soon after enrollment before starting tube feed	60 years n=27 Participants • The patient excluded from analysis were extubated too soon after enrollment before starting tube feed
Sex: Female, Male Female	25 Participants n=93 Participants	19 Participants n=4 Participants	44 Participants n=27 Participants
Sex: Female, Male Male	30 Participants n=93 Participants	28 Participants n=4 Participants	58 Participants n=27 Participants
Region of Enrollment United States	55 participants n=93 Participants	47 participants n=4 Participants	102 participants n=27 Participants

PRIMARY outcome

Timeframe: Subjects will be followed from date of randomization until discharge from the ICU or cessation of Enteral Nutrition (EN) and successful initiation of oral feeds up to 100 weeks.

1. Incidence of overt GI bleeding (as defined by the presence of coffee ground emesis, hematemesis of bright red blood, melena, or hematochezia) seen with Proton Pump Inhibitor (PPI) and EN versus EN alone in critically ill patients. 2. Incidence of significant GI bleeding, defined by a 3-point decrease in hematocrit within 24 hours accompanied by signs of overt GI bleeding, or by an unexplained 6-point decrease in hematocrit during any 48 hour period.

Outcome measures

Outcome measures
Measure	Pantoprazole 40mg IV Daily and Tube Feed n=55 Participants Pantoprazole 40 mg IV daily and tube feed.: Patients randomized to the control group "active Comparator" will receive tube feed plus an Pantoprazole 40 mg IV daily.	Placebo and Tube Feed. n=47 Participants Placebo and tube feed: Patients randomized to Placebo group "placebo Comparator" will receive tube feed plus an Placebo.
Number of Subjects With GI Bleeding	1 participants	1 participants

SECONDARY outcome

Timeframe: Subjects will be followed until discharge from the ICU or cessation of EN and successful initiation of oral feeds up to 100 weeks.

Outcome measures

Outcome measures
Measure	Pantoprazole 40mg IV Daily and Tube Feed n=55 Participants Pantoprazole 40 mg IV daily and tube feed.: Patients randomized to the control group "active Comparator" will receive tube feed plus an Pantoprazole 40 mg IV daily.	Placebo and Tube Feed. n=47 Participants Placebo and tube feed: Patients randomized to Placebo group "placebo Comparator" will receive tube feed plus an Placebo.
Number of Subjects With ICU-acquired C. Difficile Pseudomembranous Colitis.	1 Participants	3 Participants

Adverse Events

Pantoprazole 40mg IV Daily and Tube Feed

Serious events: 1 serious events

Other events: 0 other events

Deaths: 0 deaths

Placebo and Tube Feed.

Serious events: 1 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Pantoprazole 40mg IV Daily and Tube Feed n=62 participants at risk Pantoprazole 40 mg IV daily and tube feed.: Patients randomized to the control group "active Comparator" will receive tube feed plus an Pantoprazole 40 mg IV daily.	Placebo and Tube Feed. n=62 participants at risk Placebo and tube feed: Patients randomized to Placebo group "placebo Comparator" will receive tube feed plus an Placebo.
Gastrointestinal disorders GI bleed	1.6% 1/62 • Number of events 1	1.6% 1/62 • Number of events 1

Other adverse events

Adverse event data not reported

Additional Information

Dr. Mohamed Saad

University of Louisville

Phone: 5028525841

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place