NCT06584149

Brief Summary

The aim of this study is to investigate the prognostic value of Blood Urea Nitrogen to serum Albumin ratio in septic Acute Kidney Injury patients Follow-up will be conducted for all enrolled patients for 30 days from admission to record mortality and the cause of death.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
64

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Sep 2023

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

Study Start

First participant enrolled

September 25, 2023

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2024

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

August 24, 2024

Completed
11 days until next milestone

First Posted

Study publicly available on registry

September 4, 2024

Completed
21 days until next milestone

Study Completion

Last participant's last visit for all outcomes

September 25, 2024

Completed
Last Updated

February 17, 2025

Status Verified

July 1, 2024

Enrollment Period

8 months

First QC Date

August 24, 2024

Last Update Submit

February 14, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • mortality

    number of cases of mortality

    30 days

Secondary Outcomes (5)

  • mechanical ventilation

    30 days

  • stage-3 AKI

    30 days

  • renal replacement therapy

    30 days

  • septic shock

    30 days

  • length of ICU stay

    30 days

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

This prospective study will be conducted on patients with septic acute kidney injury. After admission of the patient to ICU in Ain Shams University Hospitals

You may qualify if:

  • years of age
  • Fulfilled the diagnostic criteria of Sepsis 3.0 (defined as a suspected or confirmed infection with a sequential organ failure assessment (SOFA) score of 2 or higher)
  • Developed AKI during hospitalization according to Kidney Disease: Improving Global Outcomes (KDIGO) guideline

You may not qualify if:

  • ICU length of stay\<24 h
  • AKI occurred before current hospital admission.
  • AKI is supposed to be secondary to causes other than sepsis.
  • Receiving renal replacement therapy at the time of admission.
  • Diagnosis with chronic kidney disease.
  • Diagnosis with liver failure.
  • Pregnant or lactating.
  • There was insufficient data for analysis.
  • Patients who had received Human serum Albumin infusion 3 days before ICU admission.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ain Shams University

Cairo, Abbassia, 11566, Egypt

Location

MeSH Terms

Conditions

Acute Kidney InjurySepsis

Condition Hierarchy (Ancestors)

Renal InsufficiencyKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesInfectionsSystemic Inflammatory Response SyndromeInflammationPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 24, 2024

First Posted

September 4, 2024

Study Start

September 25, 2023

Primary Completion

June 1, 2024

Study Completion

September 25, 2024

Last Updated

February 17, 2025

Record last verified: 2024-07

Data Sharing

IPD Sharing
Will not share

Locations