A Phase 4 interventional study of Human albumin and Omeprazole in Peptic Ulcer Bleeding and Hypoalbuminemia, sponsored by National Cheng-Kung University Hospital. Completed at 1 site in Taiwan. Open to participants aged 39 Years to 83 Years. Per ClinicalTrials.gov, last updated 2019-08-29.
Sponsored by National Cheng-Kung University Hospital · Phase 4, Interventional, and Treatment
To test whether intravenous albumin can decrease the rebleeding rate or shorten the duration of hospitalization in patients with peptic ulcer bleeding and hypoalbuminemia.
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.
193 studies on the registry are indexed under Peptic Ulcer; 31 are open to participants now.
This study's enrollment of 91 is below the median of 150 across 142 interventional studies indexed under Peptic Ulcer.
Browse Peptic Ulcer studies →National Cheng-Kung University Hospital is the lead sponsor of 268 studies on the registry; 68 are open to participants now.
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Exclusion Criteria:
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.
Drug: Omeprazole
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.
Drug: Human albumin · Drug: 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.
Drug: Omeprazole
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.
Also known as: Human Albumin 20%®, ZLB Behring, Marburg, Germany
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.
Also known as: Losec®, AstraZeneca, Sweden
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.
Time frame: within 28 days after the first bleeding event
the length of hospitalization
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
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 participants with massive rebleeding events in need of transarterial embolization or emergency surgery
Time frame: within 28 days after the first bleeding event
This study is completed, as verified in Mar 2013. You cannot join it, but the record below documents what was studied.
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National Cheng-Kung University Hospital