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

Phase 4

Completed

• Conditions: Hypoalbuminemia; Peptic Ulcer Bleeding
• Interventions: Drug: Human albumin; Drug: Omeprazole

• Registration Number: NCT01822600
• Lead Sponsor: National Cheng-Kung University Hospital

Brief 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.

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.

Study Timeline

• Study Start: 2010-01
• Primary Completion: 2011-08
• Study Completion: 2011-08
• Status Verified: 2013-03
• Study First Submitted: 2013-03-20
• Study First Submitted QC: 2013-03-27
• Study First Posted: 2013-04-02
• Last Update Submitted: 2019-08-27
• Last Update Posted: 2019-08-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 91

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention group	Human albumin	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.
Normal albumin group	Omeprazole	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.
Cohort control group	Omeprazole	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.
Intervention group	Omeprazole	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.

Primary Outcome Measures

Name	Time	Method
peptic ulcer rebleeding	within 28 days after the first bleeding event	rebleeding was defined as: (i) continuous melena, hematochezia, or the presence of recurrent bloody aspirates through the naso-gastric tube; and (ii) relapse of hemodynamic instability, including systolic blood pressure \< 90 mm Hg, heart rate \>120 beats per min, or a hemoglobin drop by more than 20 g/L. For each patient with either suspected or active rebleeding of peptic ulcer, gastroscopy was conducted to confirm that the bleeding source was either a peptic ulcer or other non-ulcer conditions.

Secondary Outcome Measures

Name	Time	Method
the length of hospitalization	within 28 days after the first bleeding event	the length of hospitalization after the first bleeding episode and the length of hospitalization after peptic ulcer rebleeding
the number of units of blood transfused	during the 28-day period after admission to the emergency room or after the presence of gastrointestinal bleeding signs in patients with nosocomial bleeding
the number of participants with massive rebleeding events in need of transarterial embolization or emergency surgery	within 28 days after the first bleeding event

Trial Locations

Locations (1)

National Cheng Kung University Hospital; 🇨🇳 Tainan, Taiwan