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

National Cheng-Kung University

Status and phase: Completed; Phase 4

Conditions: Hypoalbuminemia; Peptic Ulcer Bleeding

Treatments: Drug: Human albumin; Drug: Omeprazole

Study type: Interventional

Funder types: Other

Identifiers

NCT01822600

ER-98-239

Details and patient eligibility

About

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

Full 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.

Enrollment: 91 patients

Sex: All

Ages: 39 to 83 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Clinical presentations of melena, hematochezia, or hematemesis
• Gastroscopy confirmed peptic ulcers and major stigmata of recent hemorrhage
• A Rockal 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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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91 participants in 3 patient groups

Normal albumin group

Experimental group

Description:

Based on the serum albumin level at enrollment, the patients were assigned into the normal albumin group if their serum albumin ≥ 30 g/L. Patients in this group receive intravenous omeprazole treatment.

Treatment:

Drug: Omeprazole

Intervention group

Experimental group

Description:

Based on the serum albumin level at enrollment, the patients were assigned into an intervention group if their serum albumin \< 30 g/L. Patients in this group receive both Human albumin and intravenous omeprazole.

Treatment:

Drug: Omeprazole

Drug: Human albumin

Cohort control group

Experimental group

Description:

The study also included 29 patients with peptic ulcer bleeding and with hypoalbuminemia (serum albumin level \< 30 g/L), but without receiving albumin supply from our previous study to serve as the cohort control group. Patients in this group receive intravenous omeprazole treatment.

Treatment:

Drug: Omeprazole