Enteral Nutrition as Stress Ulcer Prophylaxis in Critically Ill Patients.

• Sponsor: Mohamed Saad (Other)
• Overall Status: Completed
• CT.gov ID: NCT01477320
• Collaborator: Abbott Nutrition (Industry), University of Louisville (Other)
• Enrollment: 124
• Location: 1
• Arms: 2
• Duration (Months): 34
• Patients Per Site Per Month: 3.7

Study Details

Study Description

Brief Summary

study is to determine if proton pump inhibitors plus enteral nutrition is superior to enteral nutrition alone as a stress ulcer prophylaxis strategy in critically ill patients in terms of incidence of overt and significant GI bleeding related to stress gastropathy.

Condition or Disease	Intervention/Treatment	Phase
Gastrointestinal Hemorrhage; Clostridium Difficile Colitis	Drug: Pantoprazole 40 mg IV daily and tube feed.; Other: Placebo and tube feed	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 124 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Triple (Participant, Care Provider, Investigator)
• Primary Purpose: Prevention
• Official Title: Enteral Nutrition as Stress Ulcer Prophylaxis in Critically Ill Patients. Prospective, Double-blind, Randomized, Placebo-controlled Study.
• Study Start Date: Sep 1, 2013
• Actual Primary Completion Date: Jul 1, 2016
• Actual Study Completion Date: Jul 1, 2016

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Pantoprazole 40mg IV daily and tube feed	Drug: 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.; Other Names: Tube feed formula:(Vital AF "Advanced Formula" 1.2 Cal(TM),Abbott,Columbus,OH)
Placebo Comparator: Placebo and tube feed.	Other: Placebo and tube feed; Patients randomized to Placebo group "placebo Comparator" will receive tube feed plus an Placebo.; Other Names: Tube feed formula:(Vital AF "Advanced Formula" 1.2 Cal(TM),Abbott,Columbus,OH)

Outcome Measures

Primary Outcome Measures

1. Number of Subjects With GI Bleeding [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.]

   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. 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.

Secondary Outcome Measures

1. Number of Subjects With ICU-acquired C. Difficile Pseudomembranous Colitis. [Subjects will be followed until discharge from the ICU or cessation of EN and successful initiation of oral feeds up to 100 weeks.]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Age 18 years or older

• Admission to the medical ICU at University of Louisville Hospital or Jewish Hospital

• Expected need for mechanical ventilation > 48 hours

• No contraindication to EN within the first 24 hours after admission to the ICU

Exclusion Criteria:

• Evidence of active GI bleeding during current hospitalization prior to study entry

• Admission to ICU with primary diagnosis of burn injury

• Closed head injury or increased intracranial pressure

• Partial or complete gastrectomy

• Pregnancy or lactation

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Louisville hospital	Louisville	Kentucky	United States	40202

Sponsors and Collaborators

• Mohamed Saad
• Abbott Nutrition
• University of Louisville

Investigators

• Principal Investigator: Mohamed Saad, MD, University of Louisville

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Mohamed Saad, Primary Investigator, University of Louisville
• ClinicalTrials.gov Identifier: NCT01477320
• Other Study ID Numbers: 11.0170
• First Posted: Nov 22, 2011
• Last Update Posted: Jan 16, 2018
• Last Verified: Dec 1, 2017

• Keywords provided by Mohamed Saad, Primary Investigator, University of Louisville: Enteral Nutrition; Stress Ulcer Prophylaxis; Critically Ill Patients; Overt and significant GI bleeding; Stress gastropathy; Clostridium Difficile pseudomembranous colitis; Vital AF; Small peptide fish oil structured lipids; Fructose oligosaccharide
• Additional relevant MeSH terms: Colitis; Gastrointestinal Hemorrhage; Hemorrhage; Critical Illness; Pantoprazole

Study Results

Participant Flow

Recruitment Details	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.

Arm/Group Title	Pantoprazole 40mg IV Daily and Tube Feed	Placebo and Tube Feed.
Arm/Group Description	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: Patients randomized to Placebo group "placebo Comparator" will receive tube feed plus an Placebo.
Period Title: Overall Study
STARTED	62	62
COMPLETED	55	47
NOT COMPLETED	7	15

Baseline Characteristics

Arm/Group Title	Pantoprazole 40mg IV Daily and Tube Feed	Placebo and Tube Feed.	Total
Arm/Group Description	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: Patients randomized to Placebo group "placebo Comparator" will receive tube feed plus an Placebo.	Total of all reporting groups
Overall Participants	55	47	102
Age (years) [Median (Inter-Quartile Range) ]
Median (Inter-Quartile Range) [years]	62	58	60
Sex: Female, Male (Count of Participants)
Female	25 45.5%	19 40.4%	44 43.1%
Male	30 54.5%	28 59.6%	58 56.9%
Region of Enrollment (participants) [Number]
United States	55 100%	47 100%	102 100%

Outcome Measures

1. Primary Outcome

Title	Number of Subjects With GI Bleeding
Description	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. 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.
Time Frame	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.

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Pantoprazole 40mg IV Daily and Tube Feed	Placebo and Tube Feed.
Arm/Group Description	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: Patients randomized to Placebo group "placebo Comparator" will receive tube feed plus an Placebo.
Measure Participants	55	47
Number [participants]	1 1.8%	1 2.1%

2. Secondary Outcome

Title	Number of Subjects With ICU-acquired C. Difficile Pseudomembranous Colitis.
Time Frame	Subjects will be followed until discharge from the ICU or cessation of EN and successful initiation of oral feeds up to 100 weeks.

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Pantoprazole 40mg IV Daily and Tube Feed	Placebo and Tube Feed.
Arm/Group Description	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: Patients randomized to Placebo group "placebo Comparator" will receive tube feed plus an Placebo.
Measure Participants	55	47
Count of Participants [Participants]	1 1.8%	3 6.4%

Adverse Events

Arm/Group Title	Pantoprazole 40mg IV Daily and Tube Feed		Placebo and Tube Feed.
Arm/Group Description	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: Patients randomized to Placebo group "placebo Comparator" will receive tube feed plus an Placebo.
All Cause Mortality
	Pantoprazole 40mg IV Daily and Tube Feed		Placebo and Tube Feed.
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Pantoprazole 40mg IV Daily and Tube Feed		Placebo and Tube Feed.
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	1/62 (1.6%)		1/62 (1.6%)
Gastrointestinal disorders
GI bleed	1/62 (1.6%)	1	1/62 (1.6%)	1
Other (Not Including Serious) Adverse Events
	Pantoprazole 40mg IV Daily and Tube Feed		Placebo and Tube Feed.
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/62 (0%)		0/62 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.