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Role of Midodrine and Tolvaptan in Patients With Cirrhosis With Refractory or Recurrent Ascites

NCT ID: NCT02173288

Last Updated: 2017-09-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2/PHASE3

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-07-31

Study Completion Date

2016-03-31

Brief Summary

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The development of ascites in the natural history of cirrhosis heralds a worsening of the prognosis to 50% survival at 2 years, and this deteriorates to 30-50% at 1 year when the ascites becomes refractory to medical therapy. Hemodynamic alterations and their relation to neurohumoral systems are essential in pathophysiology of ascites formation. The theory that best explain the ascites formation and sodium retention in cirrhotics is portal hypertension leading to splanchnic arterial vasodilatation leading to underfilling of arterial circulation which is sensed by the arterial and the cardiopulmonary receptors leading to sympathetic nervous system activation and activation of the anti-natriuretic factors (RAAS and arginine vasopressin), resulting in sodium and water retention. The therapeutic options available for patients with refractory ascites are serial therapeutic paracentesis, liver transplantation and transjugular intrahepatic portosystemic shunts.Vasopressin V2 receptor antagonists antagonize the antidiuretic effects of vasopressin at the V2 receptor located in the renal collecting duct, they increase free water clearance, and thus may be helpful in mobilizing excess water in conditions associated with water retention including cirrhosis. The use of V2 receptor antagonists in cirrhosis with ascites has been shown to be safe and efficacious. Midodrine, an alpha adreno receptor agonist by causing splanchnic vasoconstriction has been used in hepatorenal syndrome (HRS) and for control of ascites in patients with refractory or recurrent ascites. It is possible that vasoconstrictors and aquaretics (V2 receptor antagonists) by acting at different sites in combination may reverse some of the pathogenic events that results in refractory or recurrent ascites.There are no reports on the use of combination of midodrine and tolvaptan in the patients with cirrhosis with ascites. Therefore, we plan to study the role of midodrine, tolvaptan and their combination on systemic hemodynamics, renal functions and control of ascites in patients with cirrhosis and refractory or recurrent ascites.

Detailed Description

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Conditions

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Cirrhosis Refractory/Recurrent Ascites

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Standard medical therapy

Standard Medical therapy (n-15) with100 to 400mg spironolactone and/or 40 to 160mg furosemide.

Group Type ACTIVE_COMPARATOR

Standard medical therapy

Intervention Type DRUG

Midodrine group

Standard medical therapy (n-15) with Midodrine 7.5 mg thrice a day

Group Type ACTIVE_COMPARATOR

Standard medical therapy

Intervention Type DRUG

Midodrine

Intervention Type DRUG

Tolvaptan group

Standard medical therapy (n-15) with Tolvaptan 15 mg twice a day

Group Type ACTIVE_COMPARATOR

Standard medical therapy

Intervention Type DRUG

Tolvaptan

Intervention Type DRUG

Tolvaptan plus midodrine arm

Standard medical therapy (n-15) with Tolvaptan 15 mg twice a day and Midodrine 7.5 mg thrice a day

Group Type EXPERIMENTAL

Standard medical therapy

Intervention Type DRUG

Tolvaptan

Intervention Type DRUG

Midodrine

Intervention Type DRUG

Interventions

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Standard medical therapy

Intervention Type DRUG

Tolvaptan

Intervention Type DRUG

Midodrine

Intervention Type DRUG

Other Intervention Names

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Standard Medical therapy (n-15) with100 to 400mg spironolactone and/or 40 to 160mg furosemide. Tolvaptan 15 mg twice a day Midodrine 7.5 mg thrice a day

Eligibility Criteria

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Exclusion Criteria

* Presence of gastrointestinal bleeding, HRS, hepatic encephalopathy of grade 2 or higher or infection within 1 month preceding the study or during the study, presence of diabetes, intrinsic renal or cardiovascular disease or arterial hypertension on history and physical examination, abnormal urine analysis, chest radiograph or electrocardiogram, presence of hepatocellular carcinoma or portal vein thrombosis or treatment with drugs with known effects on systemic and renal hemodynamics within 7 days of inclusion .
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Post Graduate Institute of Medical Education and Research, Chandigarh

OTHER

Sponsor Role lead

Responsible Party

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Dr.Virendra Singh

Professor of Hepatology

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Virendra Singh

Role: STUDY_CHAIR

PGIMER, Chandigarh

Locations

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Dept. of Hepatology, PGIMER, Chandigarh

Chandigarh, , India

Site Status

Countries

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India

References

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Rai N, Singh B, Singh A, Vijayvergiya R, Sharma N, Bhalla A, Singh V. Midodrine and tolvaptan in patients with cirrhosis and refractory or recurrent ascites: a randomised pilot study. Liver Int. 2017 Mar;37(3):406-414. doi: 10.1111/liv.13250. Epub 2016 Oct 2.

Reference Type DERIVED
PMID: 27614145 (View on PubMed)

Other Identifiers

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Mido-tolvaptan 1

Identifier Type: -

Identifier Source: org_study_id