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NCT Number: NCT01822600

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

To test whether intravenous albumin can decrease the rebleeding rate or shorten the duration of hospitalization in patients with peptic ulcer bleeding and hypoalbuminemia.

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Key information

Conditions

Peptic Ulcer Bleeding Blood Protein Disorders Digestive System Diseases Duodenal Diseases Gastrointestinal Diseases Gastrointestinal Hemorrhage Hematologic Diseases Hemic and Lymphatic Diseases Hemorrhage Hypoalbuminemia Hypoproteinemia Intestinal Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Peptic Ulcer Peptic Ulcer Hemorrhage Stomach Diseases

Age range

39 year–83 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

National Cheng Kung University Hospital

Tainan, 704, Taiwan

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Human albumin

Drug

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.

Other names: Human Albumin 20%®, ZLB Behring, Marburg, Germany

Omeprazole

Drug

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 names: Losec®, AstraZeneca, Sweden

Primary outcomes

  1. 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

  1. 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

  2. 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

  3. 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

Sponsors and collaborators

Lead sponsor

National Cheng-Kung University Hospital

Other

Collaborators

  • National Science and Technology Council, Taiwan

Registry information

Official study 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

Important dates

Study start
2010
Primary completion
2011
Study completion
2011
First posted
Apr 2, 2013
Registry last updated
Aug 29, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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