Comparison of Standard Dose Versus Once a Day Intravenous... | NCT02756741

Studies
Comparison of Standard Dose Versus Once a Day Intravenous Albumin in Spontaneous Bacterial Peritonitis

NCT02756741

Sponsor

All India Institute of Medical Sciences

Status

Completed

Last Update Posted

Apr 29, 2016Estimated

Enrollment

40Actual

Phase

Not Applicable

Conditions

Cirrhosis

Interventions

ALBUMIN

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2016

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 2014

Primary Completion Date

Jul 2015Actual

Completion Date

Jul 2015Actual

First Submitted Date

Apr 24, 2016

First Submission Date that Met QC Criteria

Apr 27, 2016

First Posted Date

Apr 29, 2016Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 27, 2016

Last Update Posted Date

Apr 29, 2016Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Subrat Kumar Acharya, Professor and Head, Department of Gastroenterology, All India Institute of Medical SciencesPrincipal Investigator

Lead Sponsor

All India Institute of Medical SciencesOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The standard recommended management of spontaneous bacterial peritonitis (SBP) includes a third-generation cephalosporin (cefotaxime or ceftriaxone) and high dose albumin (1.5g/kg on day 1 and 1g/kg on day 3). The major drawback of the current recommendations is the high price of albumin. In the current randomized control trial investigators compared the effect of standard recommended dose of albumin (1.5g/kg on day 1 and 1g/kg on day 3) vs. low dose (20g/d for 5 days) on the resolution of SBP and subsequent cytokine changes in ascitic fluid and blood.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

40Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
STANDARD DOSE	Active Comparator	Albumin 1.5gm/kg on day 1 and 1gm/kg on day 3	Drug: ALBUMIN
LOW DOSE	Placebo Comparator	Albumin 20g/d for 5 days	Drug: ALBUMIN

Interventions

Name	Type	Description	Arm Group Labels	Other Names
ALBUMIN	Drug	Albumin in two different doses	LOW DOSE STANDARD DOSE

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Change in neutrophils/mm in ascitic fluid		3 days
Change in IL-6, IL-1, TNF in ascitic fluid and serum between the two groups		5 days

Secondary Outcomes

Measure	Description	Time Frame
Survival in days at the end of therapy		5 days
Differences in frequency of sepsis, renal failure and other organ failures between the two groups		5 days

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Diagnosis of SBP
Age > 18 years
Consent to participate in the trial

Exclusion Criteria:

Secondary peritonitis
Malignancies including HCC

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

IPD Sharing Statement Module

Plan to Share IPD

Yes

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D005355	Fibrosis
D006509	Hepatitis B
D014648	Varicose Veins

Ancestor Terms

ID	Term
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms
D000086982	Blood-Borne Infections
D003141	Communicable Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D000418	Albumins

Ancestor Terms

ID	Term
D011506	Proteins
D000602	Amino Acids, Peptides, and Proteins

Browse Leaves

Not provided

Browse Branches

Not provided