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A bleeding peptic ulcer remains a serious medical problem with significant morbidity and mortality. Endoscopic therapy significantly reduces further bleeding, surgery, and mortality in patients with bleeding peptic ulcers and is now recommended as the first hemostatic modality for these patients.
In the past few years, adjuvant use of a high-dose proton pump inhibitor (PPI) after endoscopic therapy has been endorsed in some studies. However, low dose of PPI has also been supported in the management of these patients.
The investigators enroll 130 patients with active bleeding or nonbleeding visible vessels in this study. They are randomly assigned as 40 mg/day or 160mg/day IV nexium group. All patients receive successful endoscopic therapy with heater probe or hemoclip placement.
In the low dose group (N=65), 40 mg IV Nexium daily is given for three days. Thereafter, the patients receive 40 mg nexium orally daily for two months. In the large dose group (N=65), 160 mg/day continuous infusion is given for three days. Thereafter, the patients receive 40 mg nexium orally daily for two months.
The primary end point is recurrent bleeding before discharge and within 14 days. At day 14, volume of blood transfused, number of surgeries performed, and the mortality rates of the two groups are compared as well.
A bleeding peptic ulcer remains a serious medical problem with significant morbidity and mortality. Endoscopic therapy significantly reduces further bleeding, surgery, and mortality in patients with bleeding peptic ulcers and is now recommended as the first hemostatic modality for these patients.
In the past few years, adjuvant use of a high-dose proton pump inhibitor (PPI) after endoscopic therapy has been endorsed in some studies. However, low dose of PPI has also been supported in the management of these patients.
We enroll 130 patients with active bleeding or nonbleeding visible vessels in this study. They are randomly assigned as 40 mg/day or 160mg/day IV nexium group. All patients receive successful endoscopic therapy with heater probe or hemoclip placement.
In the low dose group (N=65), 40 mg IV Nexium daily is given for three days. Thereafter, the patients receive 40 mg nexium orally daily for two months. In the large dose group (N=65), 160 mg/day continuous infusion is given for three days. Thereafter, the patients receive 40 mg nexium orally daily for two months.
The primary end point is recurrent bleeding before discharge and within 14 days. At day 14, volume of blood transfused, number of surgeries performed, and the mortality rates of the two groups are compared as well.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Esomeprazole | Other | Esomeprazole 40 mg IV daily is given for three days followed by40mg once daily orally for two months. |
|
| esomeprazole | Active Comparator | esomeprazole 160 mg/day continuous infusion is given for three days followed by 40mg once daily orally for two months. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Esomeprazole | Drug | Esomeprazole 40 mg IV daily is given for three days. Thereafter, the patients receive 40 mg Esomeprazole orally daily for two months. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Two different doses intravenous proton pump inhibitors in patients with peptic ulcer bleeding after successful endoscopic therapy- a prospective randomized comparative trial. | recurrent bleeding before discharge and within 14 days | two years |
| Measure | Description | Time Frame |
|---|---|---|
| Two different doses intravenous proton pump inhibitors in patients with peptic ulcer bleeding after successful endoscopic therapy- a prospective randomized comparative trial. | two years |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Hwai-jeng Lin, Doctor | Contact | 886-2-27372181 | buddhistlearning@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Hwai-jeng Lin, MD | Taipei Medical University | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Taipei Medical University Hospital | Recruiting | Taipei | Taiwan | 110 | Taiwan |
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| ID | Term |
|---|---|
| D006471 | Gastrointestinal Hemorrhage |
| ID | Term |
|---|---|
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D006470 | Hemorrhage |
| D010335 | Pathologic Processes |
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| ID | Term |
|---|---|
| D064098 | Esomeprazole |
| ID | Term |
|---|---|
| D009853 | Omeprazole |
| D053799 | 2-Pyridinylmethylsulfinylbenzimidazoles |
| D013454 | Sulfoxides |
| D013457 | Sulfur Compounds |
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| esomeprazole | Drug | esomeprazole 160 mg/day continuous infusion is given for three days. Thereafter, the patients receive 40 mg nexium orally daily for two months. |
|
|
| D013568 |
| Pathological Conditions, Signs and Symptoms |
| D009930 |
| Organic Chemicals |
| D011725 | Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D001562 | Benzimidazoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |