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

NCT01822600 | Completed Phase 4 DMC

• 1 other identifier: ER-98-239
• Study Type: interventional
• Target: 91
• Locations: 1 country
• Sites: 1

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.

Conditions

Peptic Ulcer Bleeding; Hypoalbuminemia

Keywords

hypoalbuminemia; peptic ulcer; rebleeding; hospitalization

Outcome Measures

Primary Outcomes (1)

• peptic ulcer rebleeding

  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.

  within 28 days after the first bleeding event

Secondary Outcomes (3)

• the length of hospitalization

  within 28 days after the first bleeding event

• 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

Study Arms (3)

Normal albumin group

EXPERIMENTAL

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.

Drug: Omeprazole

Intervention group

EXPERIMENTAL

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.

Drug: Human albumin; Drug: Omeprazole

Cohort control group

EXPERIMENTAL

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.

Drug: Omeprazole

Interventions

Human albumin 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.

Also known as: Human Albumin 20%®, ZLB Behring, Marburg, Germany

Intervention group

Omeprazole 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.

Also known as: Losec®, AstraZeneca, Sweden

Cohort control group; Intervention group; Normal albumin group

Eligibility Criteria

• Age: 39 Years - 83 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Clinical presentations of melena, hematochezia, or hematemesis
• Gastroscopy confirmed peptic ulcers and major stigmata of recent hemorrhage
• A Rockal score ≥ 6

You may not qualify if:

• 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.

Sponsors & Collaborators

• National Cheng-Kung University Hospital: lead
• National Science and Technology Council, Taiwan: collaborator

Study Sites (1)

National Cheng Kung University Hospital

Tainan, 704, Taiwan

Location

MeSH Terms

Conditions

Peptic Ulcer Hemorrhage; Hypoalbuminemia; Peptic Ulcer

Interventions

Serum Albumin, Human; Omeprazole

Condition Hierarchy (Ancestors)

Gastrointestinal Hemorrhage; Gastrointestinal Diseases; Digestive System Diseases; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Hypoproteinemia; Blood Protein Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Duodenal Diseases; Intestinal Diseases; Stomach Diseases

Intervention Hierarchy (Ancestors)

Serum Albumin; Albumins; Proteins; Amino Acids, Peptides, and Proteins; Blood Proteins; 2-Pyridinylmethylsulfinylbenzimidazoles; Sulfoxides; Sulfur Compounds; Organic Chemicals; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Benzimidazoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Hsiu-Chi Cheng, MD, PhD

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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 20, 2013
• First Posted: April 2, 2013
• Study Start: January 1, 2010
• Primary Completion: August 1, 2011
• Study Completion: August 1, 2011
• Last Updated: August 29, 2019

Record last verified: 2013-03

Locations

TW (1)