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

NCT ID: NCT01822600

Last Updated: 2019-08-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 91 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-01-31
• Study Completion Date: 2011-08-31

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.

Conditions

Peptic Ulcer Bleeding; Hypoalbuminemia

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Normal albumin group

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.

Group Type: EXPERIMENTAL

Omeprazole

Intervention Type: DRUG

After endoscopic hemostasis, each enrolled patient received an 80 mg loading dose of intravenous omeprazole (Losec®, AstraZeneca, Sweden) immediately. Patients then received a 3-day continuous omeprazole infusion in dosage of 80 mg per day.

After omeprazole infusion, oral esomeprazole (Nexium®, AstraZeneca, Sweden) 40 mg per day was given in the normal albumin group and the intervention group until the end of follow-up.

After omeprazole infusion, oral omeprazole (Losec®) 20 mg per day was given in the cohort control group until the end of follow-up.

Intervention group

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.

Group Type: EXPERIMENTAL

Human albumin

Intervention Type: DRUG

Each patient in the intervention group received Human Albumin 20%® (ZLB Behring, Marburg, Germany), immediately. The dosage of albumin infusion was 10 g q8h for 1 day in patients with albumin levels ranging from 25 g/L to 29 g/L or 2 days in those with albumin levels \< 25 g/L.

Omeprazole

Intervention Type: DRUG

After endoscopic hemostasis, each enrolled patient received an 80 mg loading dose of intravenous omeprazole (Losec®, AstraZeneca, Sweden) immediately. Patients then received a 3-day continuous omeprazole infusion in dosage of 80 mg per day.

After omeprazole infusion, oral esomeprazole (Nexium®, AstraZeneca, Sweden) 40 mg per day was given in the normal albumin group and the intervention group until the end of follow-up.

After omeprazole infusion, oral omeprazole (Losec®) 20 mg per day was given in the cohort control group until the end of follow-up.

Cohort control group

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.

Group Type: EXPERIMENTAL

Omeprazole

Intervention Type: DRUG

After endoscopic hemostasis, each enrolled patient received an 80 mg loading dose of intravenous omeprazole (Losec®, AstraZeneca, Sweden) immediately. Patients then received a 3-day continuous omeprazole infusion in dosage of 80 mg per day.

After omeprazole infusion, oral esomeprazole (Nexium®, AstraZeneca, Sweden) 40 mg per day was given in the normal albumin group and the intervention group until the end of follow-up.

After omeprazole infusion, oral omeprazole (Losec®) 20 mg per day was given in the cohort control group until the end of follow-up.

Interventions

Human albumin

Each patient in the intervention group received Human Albumin 20%® (ZLB Behring, Marburg, Germany), immediately. The dosage of albumin infusion was 10 g q8h for 1 day in patients with albumin levels ranging from 25 g/L to 29 g/L or 2 days in those with albumin levels \< 25 g/L.

Intervention Type: DRUG

Omeprazole

After endoscopic hemostasis, each enrolled patient received an 80 mg loading dose of intravenous omeprazole (Losec®, AstraZeneca, Sweden) immediately. Patients then received a 3-day continuous omeprazole infusion in dosage of 80 mg per day.

After omeprazole infusion, oral esomeprazole (Nexium®, AstraZeneca, Sweden) 40 mg per day was given in the normal albumin group and the intervention group until the end of follow-up.

After omeprazole infusion, oral omeprazole (Losec®) 20 mg per day was given in the cohort control group until the end of follow-up.

Intervention Type: DRUG

Other Intervention Names

Human Albumin 20%®, ZLB Behring, Marburg, Germany; Losec®, AstraZeneca, Sweden

Eligibility Criteria

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.

• Minimum Eligible Age: 39 Years
• Maximum Eligible Age: 83 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Science and Technology Council, Taiwan

OTHER_GOV

Sponsor Role: collaborator

National Cheng-Kung University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Hsiu-Chi Cheng, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Department of Internal Medicine, National Cheng Kung University Hospital, College of Medicine, National Cheng Kung University

Locations

National Cheng Kung University Hospital

Tainan City, , Taiwan

Countries

Taiwan

Other Identifiers

ER-98-239

Identifier Type: -

Identifier Source: org_study_id