Peptic Ulcer BleedingPhase 4NCT01822600
The Therapeutic Role of Intravenous Albumin Administration for Peptic Ulcer Bleeding Patients With Hypoalbuminemia
A Phase 4 study testing Human albumin and Omeprazole in people with Peptic Ulcer Bleeding and Hypoalbuminemia, run by National Cheng-Kung University Hospital at 1 site in Taiwan.
Trial 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. Read more about this study
- Who is it for?
- Ages 39 to 83 years
- Conditions the study is for
- Peptic Ulcer Bleeding, Hypoalbuminemia
- What is being tested?
- Human albumin and Omeprazole
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 91 participants
- Where
- 1 siteTaiwan
- Study dates
- Jan 2010to Aug 2011
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 39 to 83 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Clinical presentations of melena, hematochezia, or hematemesis
- Gastroscopy confirmed peptic ulcers and major stigmata of recent hemorrhage
- A Rockal score ≥ 6
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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
To test whether intravenous albumin can decrease the rebleeding rate or shorten the duration of hospitalization in patients with peptic ulcer bleeding and hypoalbuminemia.
Read the 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.
- Conditions
- Peptic Ulcer Bleeding, Hypoalbuminemia
- Being tested
- Human albumin, Omeprazole
- Keywords
- hypoalbuminemia, peptic ulcer, rebleeding, hospitalization
- Medical subject headings
- Peptic Ulcer Hemorrhage, Hypoalbuminemia, Peptic Ulcer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Human albuminDrug
Also called Human Albumin 20%®, ZLB Behring, Marburg, Germany
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.
OmeprazoleDrug
Also called Losec®, AstraZeneca, Sweden
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.
| Study group | Role | What they receive |
|---|---|---|
| Normal albumin group | Experimental | 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. Receives: Drug: Omeprazole |
| Intervention group | Experimental | 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. Receives: Drug: Human albumin; Drug: Omeprazole |
| Cohort control group | Experimental | 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. Receives: Drug: Omeprazole |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: within 28 days after the first bleeding event
Secondary outcomes (3)
the length of hospitalization
the length of hospitalization after the first bleeding episode and the length of hospitalization after peptic ulcer rebleeding
Measured: within 28 days after the first bleeding event
the number of units of blood transfused
Measured: 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
Measured: within 28 days after the first bleeding event
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Apr 2013 (estimated)
- Study startJan 2010
- Primary completionAug 2011
- Study completionAug 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Peptic Ulcer BleedingStudies of the same condition, open and under way.
- More trials run by National Cheng-Kung University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 91 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Cheng-Kung University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- National Science and Technology Council, Taiwan
- Responsible party
- Sponsor
- Investigators
- Hsiu-Chi Cheng, MD, PhD, Principal investigator, Department of Internal Medicine, National Cheng Kung University Hospital, College of Medicine, National Cheng Kung University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01822600
- Sponsor's protocol ID
- ER-98-239
- Status last verified
- Mar 2013
- First submitted
- 20 Mar 2013
- Last updated
- 29 Aug 2019
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 29 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01822600
- Acronym / sponsor ID
- ER-98-239
- Conditions
- Peptic Ulcer Bleeding, Hypoalbuminemia
- Keywords
- hypoalbuminemia, peptic ulcer, rebleeding, hospitalization
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 91 participants (actual)
- Lead sponsor
- National Cheng-Kung University HospitalUniversity, hospital or other
- Collaborators
- National Science and Technology Council, Taiwan
- Study start
- Jan 2010
- Primary completion
- Aug 2011 (actual)
- Study completion
- Aug 2011 (actual)
- First posted
- 2 Apr 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Normal albumin group | Experimental | Drug: OmeprazoleBased 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 group | Experimental | Drug: Human albumin, Drug: OmeprazoleBased 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. |
| Cohort control group | Experimental | Drug: OmeprazoleThe 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. |
Who may qualify
- Ages
- 39 to 83 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Clinical presentations of melena, hematochezia, or hematemesis
- Gastroscopy confirmed peptic ulcers and major stigmata of recent hemorrhage
- A Rockal score ≥ 6
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Human albuminAlso: Human Albumin 20%®, ZLB Behring, Marburg, GermanyEach 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. | Drug | Intervention group |
| OmeprazoleAlso: Losec®, AstraZeneca, SwedenAfter 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. | Drug | Cohort control group, Intervention group, Normal albumin group |
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.
3 secondary outcomes
the length of hospitalization
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Aug 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hsiu-Chi Cheng, MD, PhD principal investigator
Department of Internal Medicine, National Cheng Kung University Hospital, College of Medicine, National Cheng Kung University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Human albumin and Omeprazole in people with Peptic Ulcer Bleeding and Hypoalbuminemia, run by National Cheng-Kung University Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
peptic ulcer rebleeding (time frame: within 28 days after the first bleeding event). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Aug 2019.