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Intravenous Proton Pump Inhibitor for Peptic Ulcer Bleeding (PPI)

L

Lotung Poh-Ai Hospital

Status and phase

Completed
Phase 4

Conditions

Peptic Ulcer Hemorrhage

Treatments

Drug: pantoprazole

Study type

Interventional

Funder types

Other

Identifiers

NCT00731601
LotungPAH

Details and patient eligibility

About

A large dose of PPI is effective in preventing peptic ulcer rebleeding. The investigators hypothesize that 40 mg/q6h pantoloc is equivalent to 8mg/h pantoloc in preventing rebleeding.

Full description

A bleeding peptic ulcer remains a serious medical problem with significant morbidity and mortality. Endoscopic therapy significantly reduces further bleeding, surgery, and mortality in patients with bleeding peptic ulcers and is now recommended as the first hemostatic modality for these patients.

In the past few years, adjuvant use of a high-dose proton pump inhibitor (PPI) after endoscopic therapy has been endorsed in some studies, two consensus statements and two meta-analysis. In our previous experience, we used omeprazole 160 mg /day infusion instead of 8 mg/h in these patients and obtained a good result .

The objectives of this study are to assess the outcomes of two different regimens of high dose of intravenous pantoprazole after endoscopic therapy in patients with peptic ulcer bleeding.

Enrollment

120 patients

Sex

All

Ages

18 to 80 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Patients were accepted for endoscopic therapy if a peptic ulcer with active bleeding, a non-bleeding visible vessel (NBVV) or an adherent blood clot at the ulcer base was observed within 24 hours of hospital admission.

Exclusion criteria

  • If patients were pregnant
  • Did not obtain initial hemostasis with endoscopic injection of epinephrine
  • Did not give written informed consent
  • Had bleeding tendency (platelet count < 50×109/L, serum prothrombin < 30% of normal, or were taking anticoagulants), uremia.

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

120 participants in 2 patient groups

1
Experimental group
Description:
pantoprazole 40mg/q6h IV infusion for three days
Treatment:
Drug: pantoprazole
Drug: pantoprazole
2
Active Comparator group
Description:
pantoprazole 8mg/h for three days
Treatment:
Drug: pantoprazole
Drug: pantoprazole

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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