Plasma Endostatin Predicts Outcome of Septic AKI

Acute Kidney Injury Due to Sepsis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04633746
• Other study ID #: I-801016
• Status: Completed
• Start date: January 20, 2019
• Est. completion date: August 31, 2020

Study information

• Verified date: November 2020
• Source: Cairo University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: August 31, 2020
• Est. primary completion date: June 30, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Acute Kidney Injury
• Acute Kidney Injury Due to Sepsis
• Sepsis

Intervention

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

Locations

Country	Name	City	State
Egypt	Farouk Faris	Cairo	Down Town

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Renal outcme	Number of participants who have recovered renal functions & those who needed Renal replacement therapy	7 days