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Completed

NCT Number: NCT04633746

Plasma Endostatin Predicts Outcome of Septic AKI

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.

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Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Farouk Faris

Cairo, Down Town, 11345, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

  • 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.

Treatment and study plan

measuring plasma Endostatin level

Diagnostic Test

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

Primary outcomes

  1. Renal outcme

    Time frame: 7 days

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

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Registry information

Official study title

Validation of Plasma Endostatin for Predicting Renal Outcome From Acute Kidney Injury Induced by Sepsis

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Nov 18, 2020
Registry last updated
Nov 18, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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