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OpenTrials
Completed

NCT Number: NCT00590928

Gastric pH in Critically Ill Patients

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.

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Key information

Conditions

Critically Ill Patients Indication for Stress Ulcer Prophylaxis

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Medical University of Vienna, Department of Medicine III, ICU

Vienna, 1090, Austria

About this study

Gastric pH is measured continuously for 72 hours with a pipolar microelectrode placed between 7 and 15cm below the lower esophageal sphincter.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • gastrointestinal bleeding
  • gastric pH > 4

Treatment and study plan

Esomeprazole

Drug

40mg once daily

Ranitidine

Drug

50mg every h hours

Primary outcomes

  1. the percentage of time with gastric pH > 4

    Time frame: 72 hours

Secondary outcomes

  1. median gastric pH

    Time frame: 72 hours

  2. incidence of gastrointestinal bleeding

    Time frame: 72 hours

  3. incidence of ventilator associated pneumonia

    Time frame: ICU stay

  4. the percentage of time with an gastric pH > 5

    Time frame: 72 hours

Sponsors and collaborators

Lead sponsor

Medical University of Vienna

Other

Registry information

Official study title

Effect of Intravenous Esomeprazole Versus Ranitidine on Gastric pH in Critically Ill Patients - a Prospective, Randomized, Double-Blind Study.

Important dates

Study start
2004
Primary completion
2006
Study completion
2006
First posted
Jan 11, 2008
Registry last updated
Jan 11, 2008

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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