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

Primary Purpose

Peptic Ulcer Bleeding, Hypoalbuminemia

Status
Completed
Phase
Phase 4
Locations
Taiwan
Study Type
Interventional
Intervention
Human albumin
Omeprazole
Sponsored by
National Cheng-Kung University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Peptic Ulcer Bleeding focused on measuring hypoalbuminemia, peptic ulcer, rebleeding, hospitalization

Eligibility Criteria

39 Years - 83 Years (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • National Cheng Kung University Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

Normal albumin group

Intervention group

Cohort control group

Arm 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.

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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

the length of hospitalization
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
the number of participants with massive rebleeding events in need of transarterial embolization or emergency surgery

Full Information

First Posted
March 20, 2013
Last Updated
August 27, 2019
Sponsor
National Cheng-Kung University Hospital
Collaborators
National Science Council, Taiwan
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1. Study Identification

Unique Protocol Identification Number
NCT01822600
Brief Title
The Therapeutic Role of Intravenous Albumin Administration for Peptic Ulcer Bleeding Patients With Hypoalbuminemia
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 Type
Interventional

2. Study Status

Record Verification Date
March 2013
Overall Recruitment Status
Completed
Study Start Date
January 2010 (undefined)
Primary Completion Date
August 2011 (Actual)
Study Completion Date
August 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
National Cheng-Kung University Hospital
Collaborators
National Science Council, Taiwan

4. Oversight

Data Monitoring Committee
Yes

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Peptic Ulcer Bleeding, Hypoalbuminemia
Keywords
hypoalbuminemia, peptic ulcer, rebleeding, hospitalization

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
91 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Normal albumin group
Arm Type
Experimental
Arm 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.
Arm Title
Intervention group
Arm Type
Experimental
Arm 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.
Arm Title
Cohort control group
Arm Type
Experimental
Arm 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.
Intervention Type
Drug
Intervention Name(s)
Human albumin
Other Intervention Name(s)
Human Albumin 20%®, ZLB Behring, Marburg, Germany
Intervention Description
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
Intervention Name(s)
Omeprazole
Other Intervention Name(s)
Losec®, AstraZeneca, Sweden
Intervention Description
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.
Primary Outcome Measure Information:
Title
peptic ulcer rebleeding
Description
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.
Time Frame
within 28 days after the first bleeding event
Secondary Outcome Measure Information:
Title
the length of hospitalization
Description
the length of hospitalization after the first bleeding episode and the length of hospitalization after peptic ulcer rebleeding
Time Frame
within 28 days after the first bleeding event
Title
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
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
39 Years
Maximum Age & Unit of Time
83 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hsiu-Chi Cheng, MD, PhD
Organizational Affiliation
Department of Internal Medicine, National Cheng Kung University Hospital, College of Medicine, National Cheng Kung University
Official's Role
Principal Investigator
Facility Information:
Facility Name
National Cheng Kung University Hospital
City
Tainan
ZIP/Postal Code
704
Country
Taiwan

12. IPD Sharing Statement

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

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