Critically ill patients are at an increased risk of having upper gastrointestinal (GI) bleeding due to stress related mucosal damage. Cimetidine, delivered continuously through intravenous infusion, is the only drug that the FDA has approved for the prevention of upper GI bleeding in critically ill patients. The present trial is intended to assess the safety and efficacy of an omeprazole sodium bicarbonate immediate-release suspension in this indication.

Condition	Treatment or Intervention	Phase
Upper gastrointestinal bleeding	Drug: Omeprazole sodium bicarbonate immediate release PWD/FS	Phase III

Further Study Details: 

Expected Total Enrollment:  354

Ages Eligible for Study:  16 Years and above,  Genders Eligible for Study:  Both

Criteria

Patients will be included in the trial if they meet all of the following criteria:

1. An adult or adolescent (greater than or equal to 16 years of age) male or non-pregnant female requiring mechanical ventilation for greater than or equal to 48 hours.

2. An anticipated ICU stay of greater than or equal to 72 hours.

3. An Acute Physiology and Chronic Health Evaluation (APACHE II) score of >11 immediately before randomization.

4. At least one other risk factor for upper GI bleeding due to stress-related mucosal damage in addition to mechanical ventilation. Acceptable "other" risk factors include:

• closed-head injury
• multiple trauma to head, chest, abdomen, solid organs, or limbs
• major surgical procedures (eg, mastectomy, pancreatectomy, cardiovascular surgery) 24 hours previous to screening
• extensive burns (greater than or equal to 30% of the body surface area)
• acute renal failure (urine output <0.5 mL/kg of body weight/hr for one hour, despite adequate fluid resuscitation)
• acid-base disorder (pH less than or equal to 7.3 or base deficit greater than or equal to 5.0 mMol/L with a plasma lactate level >1.5 times the upper limit of normal for the reporting laboratory)
• coagulopathy (a platelet count <50,000/mm3, an INR of >1.5 [i.e., prothrombin time >1.5 times the control value], or a partial-thromboplastin time >2.0 times the control value)
• marked jaundice (defined as plasma total bilirubin concentration of >51.3 micromol/L or >3 mg/dL)
• coma
• hypotension (either a systolic blood pressure <80 mm Hg for 2 hours or more or a decrease of greater than or equal to 30 mm Hg in the systolic blood pressure)
• shock (arterial blood pressure less than or equal to 90 mm Hg or mean arterial pressure less than or equal to 70 mm Hg for at least one hour despite adequate fluid resuscitation, adequate intravascular volume status or the use of vasopressors in an attempt to maintain a systolic blood pressure of greater than or equal to 90 mm Hg or a mean arterial pressure of greater than or equal to 70 mm Hg)
• sepsis (defined as a positively cultured or clinically diagnosed infection with at least three of the following: a body temperature of greater than or equal to 38 degrees C [greater than or equal to 100.4 degrees F] or less than or equal to 36 degrees C [less than or equal to 96.8 degrees F], a heart rate of greater than or equal to 90 beats/min, tachypnea manifested by a respiratory rate of greater than or equal to 20 breaths/min, or hyperventilation as indicated by a PaCO2 of less than or equal to 32 mm Hg, and a white blood cell count of greater than or equal to 12,000 cells/mm3 or less than or equal to 4,000 cells/mm3, or the presence of >10% bands)

5. An intact stomach and a nasogastric or an orogastric tube in place.

6. An anticipation of no enteral feedings for the first two days of trial drug treatment.

Exclusion Criteria

Patients will be excluded from trial participation if they meet any of the following criteria:

1. A status of "No Cardiopulmonary Resuscitation (CPR)".

2. If >48 hours has elapsed since the patient became eligible for the trial.

3. Known history of vagotomy, pyloroplasty, gastroplasty, or any other gastric surgery.

4. Known allergy to cimetidine or omeprazole.

5. Active GI bleeding (including esophageal and gastric variceal bleeding, duodenal and gastric ulcers).

6. Significant risk of swallowing blood (i.e., severe facial trauma, oral lacerations, hemoptysis).

7. Enteral feedings for the first two days of trial drug treatment.

8. Use of an investigational drug within 30 days prior to randomization.

9. Critical/intensive care unit admission following esophageal, gastric, or duodenal surgery or trauma.

10. Known history of upper gastrointestinal lesions that are likely to bleed (e.g., esophageal or gastric varices, gastric polyps, tumors, etc. but excluding patients with gastric or duodenal ulcer disease).

11. Any medical or surgical condition that precludes administration of an oral medication (i.e., OSB-IR).

12. End stage liver disease.

Alabama
      University of South Alabama, Mobile,  Alabama,  36617,  United States
      University of Alabama at Birmingham, Birmingham,  Alabama,  35294,  United States
Arizona
      Scottsdale Healthcare, Scottsdale,  Arizona,  85258,  United States
      Maricopa Medical Center, Phoenix,  Arizona,  85008,  United States
      Arizona Pulmonary Specialists, Phoenix,  Arizona,  85006,  United States
      Arizona Pulmonary Specialists, Ltd, Phoenix,  Arizona,  85013,  United States
California
      Loma Linda Medical Center, Loma Linda,  California,  92354,  United States
      Alta Bates Summit Medical Center, Berkeley,  California,  94705,  United States
      Stanford University School of Medicine, Stanford,  California,  94305,  United States
      Providence St. Joseph's Medical Center, Burbank,  California,  91505,  United States
      Verdugo Hills Hospital, Burbank,  California,  91505,  United States
Delaware
      Christiana Hospital, Newark,  Delaware,  19718,  United States
Florida
      Shands Hospital at the University of Florida, Gainsville,  Florida,  32610,  United States
      PAB Clinical Research, Brandon,  Florida,  33511,  United States
      University of Florida, Gainsville,  Florida,  32610,  United States
      Miami VAMC, Miami,  Florida,  33125,  United States
      Jackson Memorial Hospital, Miami,  Florida,  33136,  United States
      USF Pulmonary Research, Tampa,  Florida,  33606,  United States
Georgia
      Protocare Trials, Austell,  Georgia,  30106,  United States
      Wellstar Kennestone Hospital, Marietta,  Georgia,  30060,  United States
Illinois
      Protocare - Alexian Brothers Center for Clinical Research, Elk Grove Village,  Illinois,  60007,  United States
      West Suburban Hospital, Oak Park,  Illinois,  60302,  United States
Iowa
      University of Iowa Health Care, Iowa City,  Iowa,  52242,  United States
Kansas
      Department of Medicine, Kansas City,  Kansas,  66160,  United States
Louisiana
      Louisiana State University, Shreveport,  Louisiana,  71130,  United States
      Medical Center of LA at New Orleans (LSU Health Sci Ctr), New Orleans,  Louisiana,  70112,  United States
Massachusetts
      University of Massachusetts, Worcester,  Massachusetts,  01655,  United States
      Baystate Medical Center, Springfield,  Massachusetts,  01199,  United States
Michigan
      William Beaumont Hospital, Royal Oak,  Michigan,  48073,  United States
Minnesota
      University of Minnesota, Minneapolis,  Minnesota,  55455,  United States
      Regions Hospital, St. Paul,  Minnesota,  55101,  United States
      Hennepin County Medical Center, Minneapolis,  Minnesota,  55414,  United States
Missouri
      Truman Medical Center Hospital Hill, Kansas City,  Missouri,  64108,  United States
      St. Johns Hospital, Springfield,  Missouri,  65804,  United States
      Washington University School of Medicine, St. Louis,  Missouri,  63109,  United States
Nebraska
      University of Nebraska, Omaha,  Nebraska,  68198,  United States
New Jersey
      Morristown Memorial Hospital, Morristown,  New Jersey,  07960,  United States
      University Hospital, Newark,  New Jersey,  07103,  United States
      Trinitas Hospital, Elizabeth,  New Jersey,  07207,  United States
      Cooper Hospital/UMC, Camden,  New Jersey,  08103,  United States
New York
      University of Rochester Medical Center, Rochester,  New York,  14642,  United States
      St. Vincent's Catholic Medical Center, New York,  New York,  10011,  United States
      Winthrop University Hospital, Mineola,  New York,  11501,  United States
      University of Rochester Medical Center, Rochester,  New York,  14642,  United States
      Long Island Jewish Medical Center, New Hyde Park,  New York,  11040,  United States
      SUNY Health Science Center, Brooklyn,  New York,  11203,  United States
North Carolina
      Duke University Medical Center, Durham,  North Carolina,  27710,  United States
Ohio
      Akron General Hospital, Akron,  Ohio,  44307,  United States
      The Toledo Hospital, Toledo,  Ohio,  43606,  United States
Oregon
      Oregon Health & Science University, Portland,  Oregon,  97201,  United States
Pennsylvania
      Abington Memorial Hospital, Abington,  Pennsylvania,  19001,  United States
Tennessee
      Vanderbilt University, Nashville,  Tennessee,  37212,  United States
      University of Tennessee, Memphis,  Tennessee,  38163,  United States
Texas
      Texas Tech University Health Sciences Center, Odessa,  Texas,  79763,  United States
      North Texas Affiliated Medical Group, Fort Worth,  Texas,  76104,  United States
Vermont
      University of Vermont, Burlington,  Vermont,  05401,  United States
Virginia
      Pulmonary & Critical Care, Richmond,  Virginia,  23249,  United States
West Virginia
      West Virginia University Hospitals, Inc, Morgantown,  West Virginia,  26506,  United States
Wisconsin
      Medical College of Wisconsin, Milwaukee,  Wisconsin,  53226,  United States

Study ID Numbers:  OSB-IR C03
Record last reviewed:  July 2003
Last Updated:  October 13, 2004
Record first received:  September 9, 2002
ClinicalTrials.gov Identifier:  NCT00045799
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-04-08