Clinical trial NCT01822600: 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
Overall status: COMPLETED
Phase: PHASE4
Conditions: Peptic Ulcer Bleeding
Hypoalbuminemia
Keywords: hypoalbuminemia
peptic ulcer
rebleeding
hospitalization
Lead sponsor: National Cheng-Kung University Hospital
Sponsor class: OTHER
Collaborators: name: National Science and Technology Council, Taiwan
First posted: 2013-04-02
Enrollment: 91
Sex: ALL
Minimum age (years): 39
Maximum age (years): 83
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: peptic ulcer rebleeding
timeFrame: within 28 days after the first bleeding event
Secondary outcomes:
measure: the length of hospitalization
timeFrame: within 28 days after the first bleeding event
measure: the number of units of blood transfused
timeFrame: during the 28-day period after admission to the emergency room or after the presence of gastrointestinal bleeding signs in patients with nosocomial bleeding
measure: the number of participants with massive rebleeding events in need of transarterial embolization or emergency surgery
timeFrame: within 28 days after the first bleeding event
Other outcomes:
Locations:
city: Tainan
country: Taiwan
facility: National Cheng Kung University Hospital
Study officials:
affiliation: Department of Internal Medicine, National Cheng Kung University Hospital, College of Medicine, National Cheng Kung University
name: Hsiu-Chi Cheng, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: