Single Dose Omeprazole Versus High Dose in High-risk Critically Ill Patients.

NCT03388463 | Completed

• 1 other identifier: MenoufiaU2016/2ICU
• Study Type: interventional
• Target: 110
• Locations: 0 countries
• Sites: N/A

Brief Summary

Upper gastrointestinal (GIT) bleeding is common in high risk critically ill patients. Hyperacidity has been identified as one of the main reasons for bleeding.1 2 Antacids with different treatment modalities have been studied to establish the best regimen for prophylaxis against bleeding.3 4 Proton pump inhibitors (PPI) are the most common drugs used in the medical field as antacids. The present study was carried out to investigate the beneficial effects of high dose omeprazole versus standard low dose as a prophylaxis against upper GIT bleeding in high risk critically ill patients.

Conditions

Critical Illness

Outcome Measures

Primary Outcomes (1)

• Significant upper gastrointestinal bleeding

  Vomiting of fresh blood, melena, or haematemesis.

  20 days during ICU stay.

Study Arms (2)

Omeprazole group

ACTIVE COMPARATOR

Patients received intravenous bolus of 80 mg omeprazole followed by 8mg/h infusion for the whole period of ICU stay.

Drug: Omeprazole

Placebo group

PLACEBO COMPARATOR

Patients received intravenous omeprazole 40mg bolus dose once daily followed by normal saline infusion.

Drug: Placebo group

Interventions

Omeprazole DRUG

Omeprazole 80 mg continues infusion

Also known as: Omeprazole continues infusion

Omeprazole group

Placebo group DRUG

Omeprazole 40 mg single daily dose.

Also known as: Placebo for infusion

Placebo group

Eligibility Criteria

• Age: 21 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Mechanically ventilated patients were identified as high risk patients. Patients with nasogastric tube inserted as part of their medical care were included in the study.

You may not qualify if:

• Patients admitted because of upper gastrointestinal bleeding, patients who were not scheduled for early enteral nutrition during the first 24 hours of intensive care unit (ICU) admission, patients with bleeding disorders, renal replacement therapy, history of gastric ulcer, gastric surgery, and the use of gastric antacids before ICU admission.

Sponsors & Collaborators

• Menoufia University: lead

MeSH Terms

Conditions

Critical Illness

Interventions

Omeprazole

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

2-Pyridinylmethylsulfinylbenzimidazoles; Sulfoxides; Sulfur Compounds; Organic Chemicals; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Benzimidazoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor in anaesthesia, intensive care, and pain medicine.

Study Record Dates

• First Submitted: December 24, 2017
• First Posted: January 3, 2018
• Study Start: May 11, 2016
• Primary Completion: August 14, 2017
• Study Completion: September 17, 2017
• Last Updated: January 3, 2018

Record last verified: 2017-12