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

• ClinicalTrials.gov Identifier: NCT01822600
• Recruitment Status: Completed
• First Posted: April 2, 2013
• Last Update Posted: August 29, 2019
• Sponsor: National Cheng-Kung University Hospital
• Collaborator: National Science Council, Taiwan
• Information provided by (Responsible Party): National Cheng-Kung University Hospital

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Peptic Ulcer Bleeding; Hypoalbuminemia	Drug: Human albumin; Drug: Omeprazole	Phase 4

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 Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 91 participants
• Allocation: Non-Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• 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 Start Date: January 2010
• Actual Primary Completion Date: August 2011
• Actual Study Completion Date: August 2011

Arms and Interventions

Arm	Intervention/treatment
Experimental: 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.	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.; Other Name: Losec®, AstraZeneca, Sweden
Experimental: 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.	Drug: 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.; Other Name: Human Albumin 20%®, ZLB Behring, Marburg, Germany; 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.; Other Name: Losec®, AstraZeneca, Sweden
Experimental: 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.	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.; Other Name: Losec®, AstraZeneca, Sweden

Outcome Measures

Primary Outcome Measures :

1. peptic ulcer rebleeding [ Time Frame: 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 :

1. the length of hospitalization [ Time Frame: 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
2. the number of units of blood transfused [ Time Frame: during the 28-day period after admission to the emergency room or after the presence of gastrointestinal bleeding signs in patients with nosocomial bleeding ]
3. the number of participants with massive rebleeding events in need of transarterial embolization or emergency surgery [ Time Frame: within 28 days after the first bleeding event ]

Eligibility Criteria

• Ages Eligible for Study: 39 Years to 83 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

Taiwan

National Cheng Kung University Hospital

Tainan, Taiwan, 704

Sponsors and Collaborators

National Cheng-Kung University Hospital

National Science Council, Taiwan

Investigators

• Principal Investigator: Hsiu-Chi Cheng, MD, PhD; Department of Internal Medicine, National Cheng Kung University Hospital, College of Medicine, National Cheng Kung University

More Information

• Responsible Party: National Cheng-Kung University Hospital
• ClinicalTrials.gov Identifier: NCT01822600
• Other Study ID Numbers: ER-98-239
• First Posted: April 2, 2013
• Last Update Posted: August 29, 2019
• Last Verified: March 2013

Keywords provided by National Cheng-Kung University Hospital:

hypoalbuminemia; peptic ulcer; rebleeding; hospitalization

Additional relevant MeSH terms:

Peptic Ulcer; Peptic Ulcer Hemorrhage; Hypoalbuminemia; Ulcer; Hemorrhage; Pathologic Processes; Duodenal Diseases; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Stomach Diseases; Gastrointestinal Hemorrhage; Hypoproteinemia; Blood Protein Disorders; Hematologic Diseases; Omeprazole; Anti-Ulcer Agents; Gastrointestinal Agents; Proton Pump Inhibitors; Enzyme Inhibitors; Molecular Mechanisms of Pharmacological Action