Trial Outcomes & Findings for Comparison of 24-hours Versus 72-hours of Octreotide Infusion in Preventing Early Rebleed From Esophageal Varices (NCT NCT03624517)

Last Updated: 2025-11-20

Results Overview

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

Recruitment status

TERMINATED

Study phase

PHASE4

Target enrollment

34 participants

Primary outcome timeframe

72 hours

Results posted on

2025-11-20

Participant Flow

Participant milestones

Participant milestones
Measure	24-hour octreotide infusion Patients will receive octreotide infusion over 24 hours Octreotide: Octreotide infusion for 24-hours in patients with bleeding esophageal varices.	72-hour octreotide infusion Patients will receive octreotide infusion over 72 hours Octreotide: Octreotide infusion for 24-hours in patients with bleeding esophageal varices.
Overall Study STARTED	15	19
Overall Study COMPLETED	15	19
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Comparison of 24-hours Versus 72-hours of Octreotide Infusion in Preventing Early Rebleed From Esophageal Varices

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	24-hour Octreotide Infusion n=15 Participants Patients will receive octreotide infusion over 24 hours Octreotide: Octreotide infusion for 24-hours in patients with bleeding esophageal varices.	72-hour Octreotide Infusion n=19 Participants Patients will receive octreotide infusion over 72 hours Octreotide: Octreotide infusion for 24-hours in patients with bleeding esophageal varices.	Total n=34 Participants Total of all reporting groups
Age, Continuous	52 years STANDARD_DEVIATION 16	54 years STANDARD_DEVIATION 11 • n=4 Participants	53.12 years STANDARD_DEVIATION 13.06 • n=8 Participants
Sex: Female, Male Female	7 Participants	6 Participants n=4 Participants	13 Participants n=8 Participants
Sex: Female, Male Male	8 Participants	13 Participants n=4 Participants	21 Participants n=8 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants	0 Participants n=4 Participants	0 Participants n=8 Participants
Race (NIH/OMB) Asian	0 Participants	0 Participants n=4 Participants	0 Participants n=8 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants	0 Participants n=4 Participants	0 Participants n=8 Participants
Race (NIH/OMB) Black or African American	3 Participants	0 Participants n=4 Participants	3 Participants n=8 Participants
Race (NIH/OMB) White	11 Participants	16 Participants n=4 Participants	27 Participants n=8 Participants
Race (NIH/OMB) More than one race	0 Participants	0 Participants n=4 Participants	0 Participants n=8 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants	3 Participants n=4 Participants	4 Participants n=8 Participants
Region of Enrollment United States	15 participants	19 participants n=4 Participants	34 participants n=8 Participants

PRIMARY outcome

Timeframe: 72 hours

Outcome measures

Outcome measures
Measure	24-hour octreotide infusion n=15 Participants Patients will receive octreotide infusion over 24 hours Octreotide: Octreotide infusion for 24-hours in patients with bleeding esophageal varices.	72-hour octreotide infusion n=19 Participants Patients will receive octreotide infusion over 72 hours Octreotide: Octreotide infusion for 24-hours in patients with bleeding esophageal varices.
Esophageal Varices Rebleed Within 72-hours After Control of Initial Bleed	0 Participants	1 Participants

SECONDARY outcome

Timeframe: 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

Outcome measures

Outcome measures
Measure	24-hour octreotide infusion n=15 Participants Patients will receive octreotide infusion over 24 hours Octreotide: Octreotide infusion for 24-hours in patients with bleeding esophageal varices.	72-hour octreotide infusion n=19 Participants Patients will receive octreotide infusion over 72 hours Octreotide: Octreotide infusion for 24-hours in patients with bleeding esophageal varices.
Esophageal Varices Rebleed at 7 Days and 30 Days After Control of Initial Bleed Rebleeding at 7 Days	0 Participants	1 Participants
Esophageal Varices Rebleed at 7 Days and 30 Days After Control of Initial Bleed Rebleeding at 30 Days	0 Participants	2 Participants

SECONDARY outcome

Timeframe: 7 days and 30 days

Survival at 7 days and 30 days.

Outcome measures

Outcome measures
Measure	24-hour octreotide infusion n=15 Participants Patients will receive octreotide infusion over 24 hours Octreotide: Octreotide infusion for 24-hours in patients with bleeding esophageal varices.	72-hour octreotide infusion n=19 Participants Patients will receive octreotide infusion over 72 hours Octreotide: Octreotide infusion for 24-hours in patients with bleeding esophageal varices.
Survival at 7 Days and 30 Days After Control of Initial Bleed Survival at 30 Days	15 Participants	18 Participants
Survival at 7 Days and 30 Days After Control of Initial Bleed Survival at 7 Days	15 Participants	19 Participants

Adverse Events

24-hour octreotide infusion

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

72-hour octreotide infusion

Serious events: 1 serious events

Other events: 8 other events

Deaths: 1 deaths

Serious adverse events

Serious adverse events
Measure	24-hour octreotide infusion n=15 participants at risk Patients will receive octreotide infusion over 24 hours Octreotide: Octreotide infusion for 24-hours in patients with bleeding esophageal varices.	72-hour octreotide infusion n=19 participants at risk Patients will receive octreotide infusion over 72 hours Octreotide: Octreotide infusion for 24-hours in patients with bleeding esophageal varices.
General disorders Death (Sepsis)	0.00% 0/15 • up to 30 days	5.3% 1/19 • Number of events 1 • up to 30 days

Other adverse events

Other adverse events
Measure	24-hour octreotide infusion n=15 participants at risk Patients will receive octreotide infusion over 24 hours Octreotide: Octreotide infusion for 24-hours in patients with bleeding esophageal varices.	72-hour octreotide infusion n=19 participants at risk Patients will receive octreotide infusion over 72 hours Octreotide: Octreotide infusion for 24-hours in patients with bleeding esophageal varices.
Infections and infestations Infection	0.00% 0/15 • up to 30 days	5.3% 1/19 • Number of events 1 • up to 30 days
Gastrointestinal disorders Dysphagia/Odynophagia	0.00% 0/15 • up to 30 days	10.5% 2/19 • Number of events 2 • up to 30 days
Gastrointestinal disorders Nasogastric Tube Insertion	0.00% 0/15 • up to 30 days	10.5% 2/19 • Number of events 2 • up to 30 days
Respiratory, thoracic and mediastinal disorders Mechanical Ventilation >12h	6.7% 1/15 • Number of events 1 • up to 30 days	10.5% 2/19 • Number of events 2 • up to 30 days
Vascular disorders Vasopressor Use	6.7% 1/15 • Number of events 1 • up to 30 days	5.3% 1/19 • Number of events 1 • up to 30 days

Additional Information

Dr. Don Rockey

Medical University of South Carolina

Phone: (843) 792-6982

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place