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
Overview
- Phase
- Phase 4
- Intervention
- Omeprazole
- Conditions
- Peptic Ulcer Bleeding
- Sponsor
- National Cheng-Kung University Hospital
- Enrollment
- 91
- Locations
- 1
- Primary Endpoint
- peptic ulcer rebleeding
- Status
- Completed
- Last Updated
- 6 years ago
Overview
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.
Investigators
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.
Arms & Interventions
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.
Intervention: Omeprazole
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.
Intervention: Human albumin
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.
Intervention: Omeprazole
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.
Intervention: Omeprazole
Outcomes
Primary Outcomes
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 Outcomes
- 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)