Current partner codePEPTIDESDE
NCT04028505·Phase 3·INTERVENTIONAL

Terlipressin Infusion in Variceal Hemorrhage

Status

Unknown

Phase

Phase 3

Enrollment

128

Locations

1

Results

Not posted

Publications

0

Study summary

What the protocol is testing.

Randomized, open label study of intravenous terlipressin infusion vs. bolus for the treatment of variceal hemorrhage. 24 hour regimen consisting of intravenous terlipressin will be used either at a rate of 0.5mg/hour or 2mg bolus every 4 hourly. Participants will be randomized into intervention and control arm using block randomization by computer generated random numbers. Efficacy will be assessed by clinical improvement in symptoms and signs of GI bleed. To assess safety, frequency and degree of adverse reactions will be observed. Periodic assessments until 5 days will be done consisting of physical examination, safety assessments, vital signs and lab tests.

Full detailed description

Randomized, open label trial, conducted on patients admitted with acute variceal hemorrhage at The Aga Khan University Hospital, Karachi (AKUH). Patients will be followed in clinic after discharge to assess survival for 6 weeks. Intravenous terlipressin will be obtained from Clinical Trials Unit, AKUH pharmacy in standard IV infusion form. Following complete clinical and laboratory evaluation, assessing the patient for eligibility, informed consent will be obtained from all the participants who are willing to be part of this study. After obtaining the informed consent, study participants will be randomized into the intervention arm (continuous infusion of Terlipressin) or the control arm (bolus form of Terlipressin). Participants who are randomized to the intervention arm will be administered a continuous infusion of Terlipressin at a rate of 0.5mg/hour for the first 24 hours. Participants randomized into the control group will be administered a bolus form of Terlipressin at a rate of 2mg every six hourly for the first 24 hours respectively. In case of weekends/public holidays intravenous terlipressin will be obtained from the main pharmacy of AKUH. The trial will be conducted in in-patient units of AKUH where eligible patients are admitted. It may include emergency room, special care unit and general ward. Moreover, patients will be followed up by phone calls and in outpatient's clinics to assess survival six weeks post discharge.

Interventions

Treatment arms and agents.

DRUG

Terlipressin Injectable Product

Intravenous terlipressin will be obtained from Clinical Trials Unit, AKUH pharmacy in standard IV infusion form. Participants who are randomized to the intervention arm will be administered a continuous infusion of Terlipressin at a rate of 0.5mg/hour for the first 24 hours. Participants randomized into the control group will be administered a bolus form of Terlipressin at a rate of 2mg every six hourly for the first 24 hours respectively. In case of weekends/public holidays intravenous terlipressin will be obtained from the main pharmacy of AKUH.

Timeline

From registration to results.

  1. First posted

    Jul 22, 2019

  2. Study start

    Oct 25, 2018

  3. Primary completion

    Apr 25, 2020

  4. Study completion

    Oct 25, 2020

  5. Results posted

    Not reported

  6. Registry updated

    Jul 22, 2019

Outcomes

What the study measures.

Primary outcomes

Reduction in tachycardia, measured through heart rate (>100 bpm) being displayed in the electronic monitors in wards, emergency room and out-patient clinics

Time frame · 6 weeks (Overall length of follow-up)

It will be assessed by trained research coordinator as; the number of study participants with 20% reduction in tachycardia as compared to the baseline between the two arms.

Improvement in mean arterial pressure, being displayed in the electronic monitors in wards, emergency room and out-patient clinics

Time frame · 6 weeks (Overall length of follow-up)

It will be assessed by trained research coordinator as; the number of study participants with 20% improvement in mean arterial pressure as compared to the baseline between the two arms. Adverse events related to terlipressin, such as hyponatremia, diarrhea, abdominal pain; arterial hypertension should be reported to the primary gastroenterologist between the two arms.

In-patient hospital mortality, assessed through medical records.

Time frame · Admission of patient till death in the hospital

It will be assessed through medical records, by a trained research coordinator as the number of study participants dying within the hospital between the two arms.

Failure to control bleeding as assessed by physiological parameters in the blood

Time frame · Admission of patient till discharge from the hospital

It will be assessed by a trained research coordinator as the number of participants having fresh hematemesis and 3 gm drop in hemoglobin (9% drop in hematocrit) within a 24 hours' time period between the two arms.

Incidence of Treatment-Emergent Adverse Events (Safety and Tolerability)

Time frame · 6 weeks (Overall length of follow-up)

It will be assessed by trained research coordinator as; the number of participants having experienced any adverse events such as hyponatremia, diarrhea, abdominal pain, arterial hypertension, 5 days after having terlipressin drug, between the two arms.

Secondary outcomes

Out of hospital mortality assessed through telephonic interviews from patient's caregiver

Time frame · 5 weeks after being discharged from the hospital

It will be assessed by trained research coordinator as; the number of participants dying after being discharged from the hospital between the two arms within the follow-up time period of the study.

Failure to control bleeding as assessed by physiological parameters in the blood

Time frame · 5 weeks after being discharged from the hospital

It will be assessed by trained research coordinator as the number of participants having fresh hematemesis and 3 gm drop in hemoglobin (9% drop in hematocrit) after being discharged from the hospital till three subsequent follow-up visits between the two arms.

Prolong hospital stay (> 5 days) as assessed through medical records and pre-designed questionnaire

Time frame · 5 days after admission till being discharged from the hospital

It will be assessed by trained research coordinator as; the number of participants having stayed in the hospital for more than five days between the two arms.

Eligibility

Who can take part.

Minimum age
18 Years
Maximum age
60 Years
Sex
ALL
Healthy volunteers
No

Inclusion Criteria: 1. Age between 18 to 60 years 2. Either gender 3. A diagnosis of liver cirrhosis; 4. Initial presentation with acute gastroesophageal variceal bleeding 5. Willing to provide informed consent to participate in the study (by study subject or next of kin) Exclusion Criteria: 1. Age \< 18 or \> 60 years 2. Not willing to provide consent due to any reason 3. No liver cirrhosis 4. Acute upper gastrointestinal bleeding unrelated to varices; 5. Use of somatostatin or octreotide. 6. Hepatocellular Carcinoma (HCC)outside Milan's criteria 7. Advance cardiovascular, pulmonary or renal disease (e.g. asthma, hypertension, arrhythmia, renal insufficiency) 8. History of hypersensitivity to Terlipressin 9. Pregnancy 10. Patients already admitted at AKUH who develop upper GI bleed during admission.

Study locations

1 registered sites.

Pakistan. Showing up to 24 locations stored in the fast local snapshot.

Aga Khan University Hospital

Karachi, Sindh, Pakistan

Publications

Results and literature.

No PMID-linked publications were present in this registry snapshot.

Primary links

Continue at the source.

Related trials

More studies on Terlipressin.

Related PeptideStat pages

Put the record in context.

Research pages describe evidence. Vendor pages, where available, describe independently tracked research-product listings and are not clinical recommendations.