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CompletedNCT04633746Updated Nov 18, 2020

Plasma Endostatin Predicts Outcome of Septic AKI

An observational study in Acute Kidney Injury Due to Sepsis, sponsored by Cairo University. Completed at 1 site in Egypt. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2020-11-18.

Sponsored by Cairo University · Observational

Study type
Observational
Model
Case-control
Time perspective
Prospective
Enrollment
40
Ages
18 Years to 80 Years
Sex
All
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Study summary

Introduction: Acute kidney injury (AKI) occurs up to 50% of patients admitted to intensive care unit. Plasma Endostatin, released from basement membrane of Bowman's capsule, rises early during AKI.

Aim of Work: To investigate the role of the plasma endostatin in the outcome prediction (renal recovery, ICU stay, mortality) of acute kidney injury in patients with sepsis.

Methods: a prospective, observational single center study on 40 patients with Sepsis at the Critical Care Department, Cairo University hospitals between March 2019 and November 2019. Serum plasma endostatin was measured at the day of admission \& every 48hrs (3 samples). APACHE II, SOFA scores were calculated. Forced diuresis was used if indicated.

Read the detailed description

The study was conducted on 40 patients with sepsis who admitted in the Critical Care department of Cairo University.

The sepsis is identified according to surviving sepsis campaign guidelines with use of SOFA score to establish the diagnosis.

The patients divided into 2 groups the first group included 25 patients who developed AKI as defined by KDIGO guidelines and the other group included 15 patients as a control group.

The Plasma Endostatin level is sampled in the first 24 hours of diagnosis of AKI, the estimation of plasma Endostatin level done by ELISA technique.

The results were presented in form of: descriptive, analytical and comparative data between the groups of study.

It was found that the patients with higher levels of plasma endostatin had a higher incidence of recovery from AKI and higher incidence of 28 days survival, while the patients with lower levels of plasma Endostatin below the determined Cut-off value have increased incidence of RRT .

Also that the patients with higher levels of plasma Endostatin levels were less labile to mechanical ventilation and had a higher incidence of weaning of vasopressors in comparison of the other group of lower levels of plasma Endostatin.

Plasma Endostatin levels have no difference between the AKI group and sepsis group which may need further investigations to determine its role in sepsis.

so that, the plasma Endostatin can be used as a marker of recovery from AKI.

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Conditions studied

  • Acute Kidney Injury Due to Sepsis
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In context

Sepsis

1,899 studies on the registry are indexed under Sepsis; 462 are open to participants now.

This study's enrollment of 40 is below the median of 160 across 931 observational studies indexed under Sepsis.

Browse Sepsis studies →

Lead sponsor

Cairo University is the lead sponsor of 4,780 studies on the registry; 1,427 are open to participants now.

Of its 36 completed or terminated interventional studies of FDA-regulated products, 5 (14%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

Age: 18- 80 years .

  • No gender preference

Inclusion criteria

  • Patients with sepsis defined According to Surviving Sepsis Campaign 2016 sepsis: Suspected or documented infection in addition to increase in SOFA score 2 points or more from the baseline108.
  • The patients will be followed for development of acute kidney injury (AKI) defined according to criteria established by Kidney Disease Improving Global Outcome guidelines (KDIGO) 20129 which includes any of the following criteria:

    • Increase in serum creatinine by > 0.3 mg/dl within 48 hours; or
    • Increase in serum creatinine to > 1.5 times baseline, which is Known or presumed to have occurred within the prior 7 days; or
    • Urine volume \< 0.5 ml/kg/h for 6 hours.

Exclusion criteria

Exclusion Criteria:

  • Critically ill patients with known history of CKD.
  • Patients on RRT ( intermittent or continuous)
  • Post renal AKI.
  • Not known history of nephrotoxic drug intake.
  • Patient with contrast induced nephropathy
  • Patients with cardiogenic shock who developed AKI.
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Study design

Observational model
Case-control
Time perspective
Prospective
Enrollment
40 participants (actual)
Patient registry
No

Groups and cohorts

  • sepsis with AKI

    Patients admitted with the diagnosis of sepsis associated with elevation of renal function tests

    Diagnostic Test: measuring plasma Endostatin level

  • Sepsis without AKI

    Patients admitted with the diagnosis of sepsis with no elevation of renal function tests

    Diagnostic Test: measuring plasma Endostatin level

Interventions

  • Diagnostic testmeasuring plasma Endostatin level

    measuring plasma Endostatin level at the time of admission then after 48hrs and 96 hours

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What researchers measure

Primary outcomes

  1. Renal outcme

    Number of participants who have recovered renal functions \& those who needed Renal replacement therapy

    Time frame: 7 days

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Study locations

1 site
  • Farouk Faris
    Cairo, Down Town 11345, Egypt
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References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 18, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT04633746
Lead sponsor
Cairo University
Responsible party
Mostafa Farouk (clinical professor, Cairo University) — Principal investigator
First posted
Nov 18, 2020
Start date
Jan 20, 2019
Primary completion
Jun 30, 2020
Completion
Aug 31, 2020
Last update
Nov 18, 2020

Study contacts

farouk faris
principal investigator · Cairo University

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Nov 2020. You cannot join it, but the record below documents what was studied.

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