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The Therapeutic Role of Intravenous Albumin Administration for Peptic Ulcer Bleeding Patients With Hypoalbuminemia

Information source: National Cheng-Kung University Hospital
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Peptic Ulcer Bleeding; Hypoalbuminemia

Intervention: Human albumin (Drug); Omeprazole (Drug)

Phase: Phase 4

Status: Completed

Sponsored by: National Cheng-Kung University Hospital

Official(s) and/or principal investigator(s):
Hsiu-Chi Cheng, MD, PhD, Principal Investigator, Affiliation: Department of Internal Medicine, National Cheng Kung University Hospital, College of Medicine, National Cheng Kung University

Summary

To test whether intravenous albumin can decrease the rebleeding rate or shorten the duration of hospitalization in patients with peptic ulcer bleeding and hypoalbuminemia.

Clinical Details

Official title: The Therapeutic Role of Albumin Supply on Peptic Ulcer Bleeding and the Correlation Between Clinical Course and Expression of Serum Response Factor on Ulcer Tissue and Superoxide Free Radical in Blood

Study design: Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: peptic ulcer rebleeding

Secondary outcome:

the length of hospitalization

the number of units of blood transfused

the number of paticipants with massive rebleeding events in need of transarterial embolization or emergency surgery

Detailed description: Peptic ulcer bleeding is a common but potentially lethal disease. Recurrent bleeding is an independent risk factor for mortality. Inhibition of gastric acid secretion by intravenous proton pump inhibitor infusion can have a positive impact on the prevention of ulcer rebleeding after successful endoscopic therapy. However, the rebleeding rate can still be high in patients with comorbid illnesses even after proton pump inhibitor usage. Hypoalbuminemia has been reported to be a significant predictor of poor prognosis in patients with comorbid illnesses. Low serum albumin levels are associated with poor prognosis of wound healing and peptic ulcer bleeding; therefore, it is worthy to conduct a head-to-head comparison to validate whether administration of albumin can be helpful in improving the control of bleeding peptic ulcers, especially in patients with comorbid illnesses. The albumin level may reflect upstream pathologic processes, such as stress or co-morbidities. Albumin administration may interrupt the downstream chain of poor outcome and thus maintain a favorable homeostasis in critically ill patients, and reduce morbidity. However, the clinical benefit of controlling peptic ulcer bleeding with exogenous albumin remains uncertain, and thus administration of albumin is not widely applied. Accordingly, the investigators conducted this pilot intervention to test whether short-term exogenous albumin administration can improve the control of peptic ulcer bleeding in hypoalbuminemic patients, who are at high risk of recurrent bleeding.

Eligibility

Minimum age: 39 Years. Maximum age: 83 Years. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Clinical presentations of melena, hematochezia, or hematemesis

- Gastroscopy confirmed peptic ulcers and major stigmata of recent hemorrhage

- A Rockall score ≥ 6

Exclusion Criteria:

- Gastric or esophageal, or duodenal tumor bleeding

- Ulcer due to mechanical factors

- Warfarin use

- Failure to establish hemostasis under gastroscopy

- Hypersensitivity to omeprazole, esomeprazole, albumin or any component of the

formulation.

Locations and Contacts

National Cheng Kung University Hospital, Tainan 704, Taiwan
Additional Information

Starting date: January 2010
Last updated: March 27, 2013

Page last updated: August 23, 2015

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