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

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

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

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 Summary:

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.


Sponsor: National Cheng-Kung University Hospital

Current Primary Outcome: 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.


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • 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
  • 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 ]
  • the number of paticipants with massive rebleeding events in need of transarterial embolization or emergency surgery [ Time Frame: within 28 days after the first bleeding event ]


Original Secondary Outcome: Same as current

Information By: National Cheng-Kung University Hospital

Dates:
Date Received: March 20, 2013
Date Started: January 2010
Date Completion:
Last Updated: March 27, 2013
Last Verified: March 2013