The Therapeutic Role of Intravenous Albumin Administration for Peptic Ulcer Bleeding Patients With Hypoalbuminemia
Condition: Peptic Ulcer Bleeding; Hypoalbuminemia
MeSH terms: Peptic Ulcer; Peptic Ulcer Hemorrhage; Hypoalbuminemia; Ulcer; Hemorrhage
Study type: Interventional
Phase: Phase 4

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.
    

Intervention name(s): Human albumin; Omeprazole
Intervention type(s): Drug; Drug
Intervention description(s): 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.; 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 intervention name(s): Human Albumin 20%®, ZLB Behring, Marburg, Germany; Losec®, AstraZeneca, Sweden
Intervention MeSH terms: Omeprazole
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: hypoalbuminemia; peptic ulcer; rebleeding; hospitalization