Bleeding Esophageal Varices, Esophageal Varices, Liver Cirrhoses, Upper Gastrointestinal Bleeding
Conditions
Brief summary
This study evaluates the safety and efficacy of 24-hour vs 72-hour octreotide infusion after variceal banding in cirrhotic patients with bleeding esophageal varices.
Detailed description
In cirrhotic patients with bleeding esophageal varices, standard of care therapy includes administration of octreotide infusion over 72-hours and endoscopic banding of esophageal varices. Octreotide acts to reduce the pressure in the blood vessels surrounding the liver, decreasing the propensity of bleeding from esophageal varices. The recommended duration of octreotide therapy is based largely on expert opinion, however a 72-hour duration of treatment is likely to be unnecessary and may inappropriately increase hospital and medical costs. This study aims to determine the safety of 24-hours of octreotide infusion in patients with bleeding esophageal varices.
Interventions
DRUGOctreotide
Octreotide infusion for 24-hours in patients with bleeding esophageal varices.
Sponsors
Ohio State University
University of Texas Southwestern Medical Center
University of Florida Health
Medical University of South Carolina
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Adult males and females who are 18 years of age or older. 2. Evidence or suspicion of upper gastrointestinal bleed (GIB) 3. Patient with known or suspected cirrhosis 4. Upper GIB secondary to bleeding esophageal varices as show by esophageal endoscopy, requiring endoscopic band ligation (EBL) at presentation 5. Willing and able to provide informed consent for study, or have a Legally authorized representative (LAR) provide consent if the patient is unable to do so
Exclusion criteria
1. Known upper gastrointestinal malignancy 2. Bleeding from gastric varices, with or without esophageal varices 3. Use of any other endoscopic method to stop GI bleeding beyond endoscopic band ligation 4. Variceal bleeding in the last 90 days 5. History of transjugular, intrahepatic, portosystemic shunt (TIPS) or vascular decompression surgery 6. Pregnant females 7. Incarcerated individuals 8. Myocardial infarct, cerebrovascular accident, sepsis, respiratory failure, or severe intercurrent illness within the previous 6 weeks 9. Non-cirrhotic portal hypertension causing esophageal varices 10. Known or suspected allergy to octreotide
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Esophageal Varices Rebleed Within 72-hours After Control of Initial Bleed | 72 hours | Rebleeding within 72-hours will be defined as any of the following: 1. A drop in hemoglobin by more than 20 percentage points from baseline 2. Sustained tachycardia above 100 beats per minute, with or without hematochezia or melena 3. Transfusion of \>2 unites packed red blood cells after esophageal band ligation 4. Recurrence of hematemesis or ongoing melena 5. Urgent or emergent need for Transjugular Intrahepatic Portosystemic Shunt (TIPS) to control suspected rebleeding |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Esophageal Varices Rebleed at 7 Days and 30 Days After Control of Initial Bleed | 7 days and 30 days | Rebleeding after 72-hours will be defined as: 1. Any new episode of hematemesis, melena, or hematochezia (with hemodynamic instability) 2. Drop in hemoglobin by more than 20 percentage points OR the need for \>2 units packed red blood cells 3. Need for TIPS or surgery to control suspected bleeding |
| Survival at 7 Days and 30 Days After Control of Initial Bleed | 7 days and 30 days | Survival at 7 days and 30 days. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 24-hour Octreotide Infusion Patients will receive octreotide infusion over 24 hours
Octreotide: Octreotide infusion for 24-hours in patients with bleeding esophageal varices. | 15 |
| 72-hour Octreotide Infusion Patients will receive octreotide infusion over 72 hours
Octreotide: Octreotide infusion for 24-hours in patients with bleeding esophageal varices. | 19 |
| Total | 34 |
Baseline characteristics
| Characteristic | 24-hour Octreotide Infusion | Total | 72-hour Octreotide Infusion |
|---|---|---|---|
| Age, Continuous | 52 years STANDARD_DEVIATION 16 | 53.12 years STANDARD_DEVIATION 13.06 | 54 years STANDARD_DEVIATION 11 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 3 Participants | 3 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants | 4 Participants | 3 Participants |
| Race (NIH/OMB) White | 11 Participants | 27 Participants | 16 Participants |
| Region of Enrollment United States | 15 participants | 34 participants | 19 participants |
| Sex: Female, Male Female | 7 Participants | 13 Participants | 6 Participants |
| Sex: Female, Male Male | 8 Participants | 21 Participants | 13 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 15 | 1 / 19 |
| other Total, other adverse events | 2 / 15 | 8 / 19 |
| serious Total, serious adverse events | 0 / 15 | 1 / 19 |
Outcome results
Primary
Esophageal Varices Rebleed Within 72-hours After Control of Initial Bleed
Rebleeding within 72-hours will be defined as any of the following: 1. A drop in hemoglobin by more than 20 percentage points from baseline 2. Sustained tachycardia above 100 beats per minute, with or without hematochezia or melena 3. Transfusion of \>2 unites packed red blood cells after esophageal band ligation 4. Recurrence of hematemesis or ongoing melena 5. Urgent or emergent need for Transjugular Intrahepatic Portosystemic Shunt (TIPS) to control suspected rebleeding
Time frame: 72 hours
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| 24-hour octreotide infusion | Esophageal Varices Rebleed Within 72-hours After Control of Initial Bleed | 0 Participants |
| 72-hour octreotide infusion | Esophageal Varices Rebleed Within 72-hours After Control of Initial Bleed | 1 Participants |
Secondary
Esophageal Varices Rebleed at 7 Days and 30 Days After Control of Initial Bleed
Rebleeding after 72-hours will be defined as: 1. Any new episode of hematemesis, melena, or hematochezia (with hemodynamic instability) 2. Drop in hemoglobin by more than 20 percentage points OR the need for \>2 units packed red blood cells 3. Need for TIPS or surgery to control suspected bleeding
Time frame: 7 days and 30 days
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| 24-hour octreotide infusion | Esophageal Varices Rebleed at 7 Days and 30 Days After Control of Initial Bleed | Rebleeding at 7 Days | 0 Participants |
| 24-hour octreotide infusion | Esophageal Varices Rebleed at 7 Days and 30 Days After Control of Initial Bleed | Rebleeding at 30 Days | 0 Participants |
| 72-hour octreotide infusion | Esophageal Varices Rebleed at 7 Days and 30 Days After Control of Initial Bleed | Rebleeding at 7 Days | 1 Participants |
| 72-hour octreotide infusion | Esophageal Varices Rebleed at 7 Days and 30 Days After Control of Initial Bleed | Rebleeding at 30 Days | 2 Participants |
Secondary
Survival at 7 Days and 30 Days After Control of Initial Bleed
Survival at 7 days and 30 days.
Time frame: 7 days and 30 days
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| 24-hour octreotide infusion | Survival at 7 Days and 30 Days After Control of Initial Bleed | Survival at 7 Days | 15 Participants |
| 24-hour octreotide infusion | Survival at 7 Days and 30 Days After Control of Initial Bleed | Survival at 30 Days | 15 Participants |
| 72-hour octreotide infusion | Survival at 7 Days and 30 Days After Control of Initial Bleed | Survival at 7 Days | 19 Participants |
| 72-hour octreotide infusion | Survival at 7 Days and 30 Days After Control of Initial Bleed | Survival at 30 Days | 18 Participants |