Safety and Efficacy of Terlipressin and Noradrenaline and Predictive Factors of Response in Type 2 HRSPhase 3Type2 HRSNCT01637454
TYPE 2 HEPATORENAL SYNDROME
A Phase 3 study testing Noradrenaline and Terlipressin in people with Safety and Efficacy of Terlipressin and Noradrenaline and Predictive Factors of Response in Type 2 HRS, run by Post Graduate Institute of Medical Education and Research, Chandigarh at 1 site in India.
Trial summary
Various vasoconstrictors have shown promising results in the management of type 1 hepatorenal syndrome (HRS). However, there are very few studies on vasopressors in the management of type 2 HRS. Terlipressin has been used commonly; however it is costly and not available in some countries. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Safety and Efficacy of Terlipressin and Noradrenaline and Predictive Factors of Response in Type 2 HRS
- What is being tested?
- Noradrenaline and Terlipressin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 46 participants
- Where
- 1 siteIndia
- Study dates
- Jan 2009to Dec 2011
- Phase
- Phase 3
- 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 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Cirrhosis with ascites with serum creatinine more than 1.5 mg/dl and less than 2.5 mg/dl
- Absence of shock, fluid losses and treatment with nephrotoxic drug
- No improvement in renal function following diuretic withdrawal and plasma volume expansion
- No ultrasound evidence of renal parenchymal disease or obstructive uropathy 5.Absence of proteinuria more than 500 mg/24 hour
Who cannot join
- Patients with history of coronary artery disease
- Cardiomyopathy
- Ventricular arrhythmia
- Obstructive arterial disease of limbs -
Trial locations and contacts
1 site in 1 country.
India1 site
Postgraduate Institute of Medical Education and Research Chandigarh
Chandigarh, Chandigarh, 160012
About this study
Official title: NORADRENALINE VERSUS TERLIPRESSIN IN THE TREATMENT OF TYPE 2 HEPATORENAL SYNDROME:A RANDOMIZED STUDY
Various vasoconstrictors have shown promising results in the management of type 1 hepatorenal syndrome (HRS). However, there are very few studies on vasopressors in the management of type 2 HRS. Terlipressin has been used commonly; however it is costly and not available in some countries. In the present study, the investigators evaluated safety and efficacy of terlipressin and noradrenaline in the treatment of type 2 HRS
- Being tested
- Noradrenaline, Terlipressin
- Keywords
- noradrenaline terlipressin type 2 HRS
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NoradrenalineDrug
Patients in group B received a continuous infusion of noradrenaline at an initial dose of 0.5 mg/hour, designed to achieve an increase in mean arterial pressure (MAP) of at least 10mmHg or an increase in 4-h urine output to more than 200 mL. When one of these goals was not achieved, the noradrenaline dose increased every 4 hour in steps of 0.5 mg/hour, up to the maximum dose of 3 mg/hour
TerlipressinDrug
Patients in group A received terlipressin as an intravenous bolus of 0.5 mg every 6 h. If a significant reduction in serum creatinine level (≥1 mg/dL) was not observed during 3-day period, the dose of terlipressin was increased in a stepwise fashion every 3 days to a maximum of 2 mg every 6 hour
| Study group | Role | What they receive |
|---|---|---|
| Terlipressin and Type-2 HRS | Active comparator | Patients in group A received terlipressin as an intravenous bolus of 0.5 mg every 6 h. If a significant reduction in serum creatinine level (≥1 mg/dL) was not observed during 3-day period, the dose of terlipressin was increased in a stepwise fashion every 3 days to a maximum of 2 mg every 6 hour. Receives: Drug: Noradrenaline; Drug: Terlipressin |
| Noradrenaline and Type-2 HRS | Active comparator | Patients in group B received a continuous infusion of noradrenaline at an initial dose of 0.5 mg/hour, designed to achieve an increase in mean arterial pressure (MAP) of at least 10mmHg or an increase in 4-h urine output to more than 200 mL. When one of these goals was not achieved, the noradrenaline dose increased every 4 hour in steps of 0.5 mg/hour, up to the maximum dose of 3 mg/hour Receives: Drug: Noradrenaline; Drug: Terlipressin |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary end point of the study was serum creatinine less than 1.5 mg
Measured: 15 days
Secondary outcomes (1)
Secondary end points include death of patients
Measured: 15 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2012 (estimated)
- Study startJan 2009
- Primary completionDec 2011
- Study completionDec 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Safety and Efficacy of Terlipressin and Noradrenaline and Predictive Factors of Response in Type 2 HRSStudies of the same condition, open and under way.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 46 participants (actual)
Sponsor and investigators
- Lead sponsor
- Post Graduate Institute of Medical Education and Research, Chandigarh
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Arun Sharma, Post Graduate Institute of Medical Education and Research, Chandigarh
- Investigators
- Virendra Singh, DM, Principal investigator, Post Graduate Institute of Medical Education and Research, Chandigarh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01637454
- Sponsor's protocol ID
- PGIMERIndia
- Acronym
- Type2 HRS
- Status last verified
- Jul 2012
- First submitted
- 28 Jun 2012
- Last updated
- 11 Jul 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
Alessandria C, Ottobrelli A, Debernardi-Venon W, Todros L, Cerenzia MT, Martini S, Balzola F, Morgando A, Rizzetto M, Marzano A. Noradrenalin vs terlipressin in patients with hepatorenal syndrome: a prospective, randomized, unblinded, pilot study. J Hepatol. 2007 Oct;47(4):499-505. doi: 10.1016/j.jhep.2007.04.010. Epub 2007 May 24.
PubMed 17560680Ghosh S, Choudhary NS, Sharma AK, Singh B, Kumar P, Agarwal R, Sharma N, Bhalla A, Chawla YK, Singh V. Noradrenaline vs terlipressin in the treatment of type 2 hepatorenal syndrome: a randomized pilot study. Liver Int. 2013 Sep;33(8):1187-93. doi: 10.1111/liv.12179. Epub 2013 Apr 21.
PubMed 23601499
Study at a glance
From the registry record, last updated by the sponsor on 11 Jul 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- NORADRENALINE VERSUS TERLIPRESSIN IN THE TREATMENT OF TYPE 2 HEPATORENAL SYNDROME:A RANDOMIZED STUDY
- ClinicalTrials.gov ID
- NCT01637454
- Acronym / sponsor ID
- Type2 HRS / PGIMERIndia
- Keywords
- noradrenaline terlipressin type 2 HRS
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 46 participants (actual)
- Lead sponsor
- Post Graduate Institute of Medical Education and Research, ChandigarhUniversity, hospital or other
- Study start
- Jan 2009
- Primary completion
- Dec 2011 (actual)
- Study completion
- Dec 2011 (actual)
- First posted
- 11 Jul 2012 (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.
Various vasoconstrictors have shown promising results in the management of type 1 hepatorenal syndrome (HRS). However, there are very few studies on vasopressors in the management of type 2 HRS. Terlipressin has been used commonly; however it is costly and not available in some countries. In the present study, the investigators evaluated safety and efficacy of terlipressin and noradrenaline in the treatment of type 2 HRS
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Terlipressin and Type-2 HRS | Active comparator | Drug: Noradrenaline, Drug: TerlipressinPatients in group A received terlipressin as an intravenous bolus of 0.5 mg every 6 h. If a significant reduction in serum creatinine level (≥1 mg/dL) was not observed during 3-day period, the dose of terlipressin was increased in a stepwise fashion every 3 days to a maximum of 2 mg every 6 hour. |
| Noradrenaline and Type-2 HRS | Active comparator | Drug: Noradrenaline, Drug: TerlipressinPatients in group B received a continuous infusion of noradrenaline at an initial dose of 0.5 mg/hour, designed to achieve an increase in mean arterial pressure (MAP) of at least 10mmHg or an increase in 4-h urine output to more than 200 mL. When one of these goals was not achieved, the noradrenaline dose increased every 4 hour in steps of 0.5 mg/hour, up to the maximum dose of 3 mg/hour |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Cirrhosis with ascites with serum creatinine more than 1.5 mg/dl and less than 2.5 mg/dl
- Absence of shock, fluid losses and treatment with nephrotoxic drug
- No improvement in renal function following diuretic withdrawal and plasma volume expansion
- No ultrasound evidence of renal parenchymal disease or obstructive uropathy 5.Absence of proteinuria more than 500 mg/24 hour
Key exclusion criteria (4 listed)
- Patients with history of coronary artery disease
- Cardiomyopathy
- Ventricular arrhythmia
- Obstructive arterial disease of limbs -
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 |
|---|---|---|
| NoradrenalinePatients in group B received a continuous infusion of noradrenaline at an initial dose of 0.5 mg/hour, designed to achieve an increase in mean arterial pressure (MAP) of at least 10mmHg or an increase in 4-h urine output to more than 200 mL. When one of these goals was not achieved, the noradrenaline dose increased every 4 hour in steps of 0.5 mg/hour, up to the maximum dose of 3 mg/hour | Drug | Noradrenaline and Type-2 HRS, Terlipressin and Type-2 HRS |
| TerlipressinPatients in group A received terlipressin as an intravenous bolus of 0.5 mg every 6 h. If a significant reduction in serum creatinine level (≥1 mg/dL) was not observed during 3-day period, the dose of terlipressin was increased in a stepwise fashion every 3 days to a maximum of 2 mg every 6 hour | Drug | Noradrenaline and Type-2 HRS, Terlipressin and Type-2 HRS |
Primary outcome
The primary end point of the study was serum creatinine less than 1.5 mg
Time frame: 15 days
1 secondary outcome
Secondary end points include death of patients
Time frame: 15 days
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 11 Jul 2012.
- Results publication: PubMed 17560680Alessandria C, Ottobrelli A, Debernardi-Venon W, Todros L, Cerenzia MT, Martini S, Balzola F, Morgando A, Rizzetto M, Marzano A. Noradrenalin vs terlipressin in patients with hepatorenal syndrome: a prospective, randomized, unblinded, pilot study. J Hepatol. 2007 Oct;47(4):499-505. doi: 10.1016/j.jhep.2007.04.010. Epub 2007 May 24.
- Derived from this study: PubMed 23601499Ghosh S, Choudhary NS, Sharma AK, Singh B, Kumar P, Agarwal R, Sharma N, Bhalla A, Chawla YK, Singh V. Noradrenaline vs terlipressin in the treatment of type 2 hepatorenal syndrome: a randomized pilot study. Liver Int. 2013 Sep;33(8):1187-93. doi: 10.1111/liv.12179. Epub 2013 Apr 21.
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.
Virendra Singh, DM principal investigator
Post Graduate Institute of Medical Education and Research, Chandigarh
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Noradrenaline and Terlipressin in people with Safety and Efficacy of Terlipressin and Noradrenaline and Predictive Factors of Response in Type 2 HRS, run by Post Graduate Institute of Medical Education and Research, Chandigarh at 1 site in India.
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 4 inclusion and 4 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 11 Jul 2012. 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 India. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
The primary end point of the study was serum creatinine less than 1.5 mg (time frame: 15 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01637454, which also lists 2 linked publications.
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 11 Jul 2012.