Hepato-Renal SyndromeNCT04522297
Nor-epinephrine Versus Midodrine/Octreotide in Patients With Hepatorenal Syndrome
A study testing Midodrine/Octreotide and Nor-epinephrine in people with Hepato-Renal Syndrome, run by National Hepatology & Tropical Medicine Research Institute at 1 site in Egypt.
Trial summary
Hepatorenal syndrome is a functional renal impairment occurring in cirrhotic patients . It develops secondary to splanchnic arterial vasodilatation which decreases the effective blood volume, activate the renin-angiotensin-aldosterone system, and stimulate of sympathetic nervous system.This study aims to compare the… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Hepato-Renal Syndrome
- What is being tested?
- Midodrine/Octreotide and Nor-epinephrine
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 91 participants
- Where
- 1 siteEgypt
- Study dates
- 15 Apr 2018to 23 Jan 2020
- Phase
- Interventional
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Both sexes aged 18 years or older having cirrhosis, ascites, and a diagnosis of HRS-AKI based on the 2015 International Club of Ascites (ICA) diagnostic criteria
Who cannot join
- Serum creatinine (sCr) >7 mg/dL Hypotension (mean arterial pressure (MAP) <70 mm Hg) or sepsis. Recent treatment with vasopressors. Patients with severe cardiovascular disease Known allergy to study medications
Trial locations and contacts
1 site in 1 country.
Egypt1 site
The National Hepatology and Tropical Research medicine institute
Cairo
About this study
Official title: Nor-epinephrine Versus Midodrine/Octreotide in Patients With Hepatorenal Acute Kidney Injury
Hepatorenal syndrome is a functional renal impairment occurring in cirrhotic patients . It develops secondary to splanchnic arterial vasodilatation which decreases the effective blood volume, activate the renin-angiotensin-aldosterone system, and stimulate of sympathetic nervous system.This study aims to compare the efficacy of nor-epinephrine versus midodrine/ octreotide, together with intravenous albumin on renal functions of patients with hepatorenal acute kidney injury.
- Conditions
- Hepato-Renal Syndrome
- Being tested
- Midodrine/Octreotide, Nor-epinephrine
- Medical subject headings
- Hepatorenal Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Midodrine/OctreotideDrug
Also called albumin at doses of 20 to 40 g/day
oral midodrine plus octreotide as subcutaneous injection
Nor-epinephrineDrug
Also called albumin at doses of 20 to 40 g/day
Intravenous infusion norepinephrine
| Study group | Role | What they receive |
|---|---|---|
| Midodrine/Octreotide | Experimental | oral midodrine plus octreotide as subcutaneous injection Receives: Drug: Midodrine/Octreotide |
| Nor-epinephrine | Active comparator | Intravenous infusion norepinephrine Receives: Drug: Nor-epinephrine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Full response
the proportion of patients achieved full response defined as return of serum creatinine to a value within 0.3 mg/dl of the baseline value
Measured: 10 days
Secondary outcomes (2)
Partial response
defined as a regression of at least one acute kidney injury stage with a fall in the serum creatinine value to ≥0.3 mg/dl above the baseline serum creatinine value
Measured: 10 days
Reversal
Incidence of HRS reversal defined as at least one serum creatinine value of ≤ 1.5 mg/dl while on treatment.
Measured: 10 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2020
- Study start15 Apr 2018
- Primary completion23 Jan 2020
- Study completion23 Jan 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepato-Renal SyndromeStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 91 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Hepatology & Tropical Medicine Research Institute
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Doaa abdelaziz, National Hepatology & Tropical Medicine Research Institute
- Investigators
- Doaa Abdelaziz yousef, Ph.D, Study director, Fellow at The National Hepatology and Tropical Research medicine institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04522297
- Sponsor's protocol ID
- 02-2018
- Status last verified
- Aug 2020
- First submitted
- 18 Aug 2020
- Last updated
- 21 Aug 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Nor-epinephrine Versus Midodrine/Octreotide in Patients With Hepatorenal Acute Kidney Injury
- ClinicalTrials.gov ID
- NCT04522297
- Acronym / sponsor ID
- 02-2018
- Conditions
- Hepato-Renal Syndrome
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 91 participants (actual)
- Lead sponsor
- National Hepatology & Tropical Medicine Research InstituteOther government
- Study start
- 15 Apr 2018 (actual)
- Primary completion
- 23 Jan 2020 (actual)
- Study completion
- 23 Jan 2020 (actual)
- First posted
- 21 Aug 2020 (actual)
- 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.
Hepatorenal syndrome is a functional renal impairment occurring in cirrhotic patients . It develops secondary to splanchnic arterial vasodilatation which decreases the effective blood volume, activate the renin-angiotensin-aldosterone system, and stimulate of sympathetic nervous system.This study aims to compare the efficacy of nor-epinephrine versus midodrine/ octreotide, together with intravenous albumin on renal functions of patients with hepatorenal acute kidney injury.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Midodrine/Octreotide | Experimental | Drug: Midodrine/Octreotideoral midodrine plus octreotide as subcutaneous injection |
| Nor-epinephrine | Active comparator | Drug: Nor-epinephrineIntravenous infusion norepinephrine |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Both sexes aged 18 years or older having cirrhosis, ascites, and a diagnosis of HRS-AKI based on the 2015 International Club of Ascites (ICA) diagnostic criteria
Key exclusion criteria (1 listed)
- Serum creatinine (sCr) >7 mg/dL Hypotension (mean arterial pressure (MAP) <70 mm Hg) or sepsis. Recent treatment with vasopressors. Patients with severe cardiovascular disease Known allergy to study medications
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 |
|---|---|---|
| Midodrine/OctreotideAlso: albumin at doses of 20 to 40 g/dayoral midodrine plus octreotide as subcutaneous injection | Drug | Midodrine/Octreotide |
| Nor-epinephrineAlso: albumin at doses of 20 to 40 g/dayIntravenous infusion norepinephrine | Drug | Nor-epinephrine |
Primary outcome
Full response
Time frame: 10 days
the proportion of patients achieved full response defined as return of serum creatinine to a value within 0.3 mg/dl of the baseline value
2 secondary outcomes
Partial response
Time frame: 10 days
Reversal
Time frame: 10 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 21 Aug 2020.
- Individual participant dataSharing planned: No
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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.
Doaa Abdelaziz yousef, Ph.D study director
Fellow at The National Hepatology and Tropical Research medicine institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Midodrine/Octreotide and Nor-epinephrine in people with Hepato-Renal Syndrome, run by National Hepatology & Tropical Medicine Research Institute at 1 site in Egypt.
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 1 inclusion and 1 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 21 Aug 2020. 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 Egypt. 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.
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?
Full response (time frame: 10 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 21 Aug 2020.