NCT04437810

Brief Summary

The role of Albumin in prevention and Treatment of Acute Kidney Injury (AKI) in patients with Spontaneous Bacterial Peritonitis (SBP) who are at high risk of AKI development has been clearly defined , which decreases the morbidity and mortality. But the role of Albumin in patient with SBP who are at low risk of AKI development (Serum Bilirubin \<4mg/dl, Creatinine \<1mg/dl at the time of presentation) has been controversial and there are no placebo controlled trials. We propose that Albumin at the standard doses is beneficial in preventing development of AKI in patients with SBP who are at low risk of AKI development.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jul 2020

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 15, 2020

Completed
3 days until next milestone

First Posted

Study publicly available on registry

June 18, 2020

Completed
20 days until next milestone

Study Start

First participant enrolled

July 8, 2020

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2022

Completed
Last Updated

January 31, 2022

Status Verified

January 1, 2022

Enrollment Period

1.8 years

First QC Date

June 15, 2020

Last Update Submit

January 27, 2022

Conditions

Liver CirrhosisAcute Kidney Injury

Outcome Measures

Primary Outcomes (1)

  • Proportion of patients having development / progression of Acute Kidney Injury in both groups.

    Day 7

Secondary Outcomes (8)

  • Resolution of Spontaneous Bacterial Peritonitis in both groups

    Day 2

  • Resolution of Spontaneous Bacterial Peritonitis in both groups

    Day 7

  • Change in PRA in both groups

    Day 7

  • Change in TNF-alpha in both groups

    Day 7

  • Change in IL-6 in both groups

    Day 7

  • +3 more secondary outcomes

Study Arms (2)

Albumin+ SMT

EXPERIMENTAL

Patients in the Albumin Arm will receive Human Albumin 20% 1.5g/kg body weight (Maximum 100g) within 6 hours from the time of diagnosis over a period of 12 hours, followed by 1g/kg bodyweight (Maximum 100g) over a period of 12 hours after 48 hours of diagnosis.(D3) along with standard medical therapy

Biological: AlbuminOther: Standard Medical Treatment

Placebo+SMT

PLACEBO COMPARATOR

\- Patients in placebo arm will receive similar volume of isotonic fluid (saline) over same duration of time along with standard medical therapy

Other: Standard Medical Treatment

Interventions

AlbuminBIOLOGICAL

\- Patients in the Albumin Arm will receive Human Albumin 20% 1.5g/kg body weight (Maximum 100g) within 6 hours from the time of diagnosis over a period of 12 hours, followed by 1g/kg bodyweight (Maximum 100g) over a period of 12 hours after 48 hours of diagnosis.(D3)

Albumin+ SMT
Standard Medical TreatmentOTHER

standard medical therapy

Albumin+ SMTPlacebo+SMT

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients who are above 18 years of age
  • Patients with Cirrhosis and SBP (community acquired /Health care associated/ nosocomial) with baseline Creatinine \<1mg/dl, Bilirubin \<4mg/dl

You may not qualify if:

  • Antibiotic treatment within one week before the diagnosis of SBP (except for prophylactic treatment with norfloxacin)
  • Significant cardiac failure, pulmonary disease
  • Known Chronic Kidney Disease or findings suggestive of organic nephropathy (proteinuria, haematuria, or abnormal findings on renal USG)
  • Hepatocellular carcinoma
  • HIV infection;
  • GI bleed within 1 month before the study
  • Ileus
  • Grade 3 to 4 hepatic encephalopathy
  • Other types of infection
  • Shock
  • Serum Bilirubin ≥4 mg/dL and Serum Creatinine ≥ 1 mg/dl at presentation
  • Patients requiring Albumin for any other indication.
  • Presence of any potential causes of dehydration (such as diarrhea or an intense response to diuretic treatment) within one week before the diagnosis of SBP).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Institute of Liver & Biliary Sciences

New Delhi, National Capital Territory of Delhi, 110070, India

RECRUITING

MeSH Terms

Conditions

Liver CirrhosisAcute Kidney Injury

Interventions

Albumins

Condition Hierarchy (Ancestors)

Liver DiseasesDigestive System DiseasesFibrosisPathologic ProcessesPathological Conditions, Signs and SymptomsRenal InsufficiencyKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital Diseases

Intervention Hierarchy (Ancestors)

ProteinsAmino Acids, Peptides, and Proteins

Central Study Contacts

Dr Venishetty Shantan, MD

CONTACT

01146300000venishantan@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 15, 2020

First Posted

June 18, 2020

Study Start

July 8, 2020

Primary Completion

April 30, 2022

Study Completion

April 30, 2022

Last Updated

January 31, 2022

Record last verified: 2022-01

Locations

IN(1)