NCT00590928

Brief Summary

H2-receptor antagonists are the gold standard for stress ulcer prophylaxis in critically ill patients. Various studies demonstrated superiority of proton pump inhibitors over H2-receptor antagonists in increasing gastric pH and in healing gastric acid-dependent diseases. It is unknown, whether proton pump inhibitors are more effective in increasing gastric pH than H2-receptor antagonists in critically ill patients requiring stress ulcer prophylaxis.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
75

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Jul 2004

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2004

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2006

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2006

Completed
1.6 years until next milestone

First Submitted

Initial submission to the registry

December 26, 2007

Completed
16 days until next milestone

First Posted

Study publicly available on registry

January 11, 2008

Completed
Last Updated

January 11, 2008

Status Verified

December 1, 2007

Enrollment Period

1.9 years

First QC Date

December 26, 2007

Last Update Submit

December 26, 2007

Conditions

Critically Ill PatientsIndication for Stress Ulcer Prophylaxis

Outcome Measures

Primary Outcomes (1)

  • the percentage of time with gastric pH > 4

    72 hours

Secondary Outcomes (4)

  • median gastric pH

    72 hours

  • incidence of gastrointestinal bleeding

    72 hours

  • incidence of ventilator associated pneumonia

    ICU stay

  • the percentage of time with an gastric pH > 5

    72 hours

Study Arms (2)

1

ACTIVE COMPARATOR

patients with indication for stress ulcer prophylaxis and gastric pH \< 4

Drug: esomeprazole

2

ACTIVE COMPARATOR

patients with indication for stress ulcer prophylaxis and gastric pH \< 4

Drug: ranitidine

Interventions

esomeprazoleDRUG

40mg once daily

1
ranitidineDRUG

50mg every h hours

2

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • critically ill patients
  • indication for stress ulcer prophylaxis
  • gastric pH \< 4

You may not qualify if:

  • gastrointestinal bleeding
  • gastric pH \> 4

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Medical University of Vienna, Department of Medicine III, ICU

Vienna, 1090, Austria

Location

MeSH Terms

Interventions

EsomeprazoleRanitidine

Intervention Hierarchy (Ancestors)

Omeprazole2-PyridinylmethylsulfinylbenzimidazolesSulfoxidesSulfur CompoundsOrganic ChemicalsPyridinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsBenzimidazolesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingFurans

Study Officials

  • Christian Madl, MD

    Medical University of Vienna

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

December 26, 2007

First Posted

January 11, 2008

Study Start

July 1, 2004

Primary Completion

June 1, 2006

Study Completion

June 1, 2006

Last Updated

January 11, 2008

Record last verified: 2007-12

Locations

AU(1)