Plasma Endostatin Predicts Outcome of Septic AKI

NCT04633746 | Completed

• 1 other identifier: I-801016
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Acute Kidney Injury Due to Sepsis

Outcome Measures

Primary Outcomes (1)

• Renal outcme

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

  7 days

Study Arms (2)

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

measuring plasma Endostatin level DIAGNOSTIC_TEST

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

Sepsis without AKI; sepsis with AKI

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Age: 18- 80 years . \- No gender preference

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Farouk Faris

Cairo, Down Town, 11345, Egypt

Location

Study Officials

• farouk faris

  Cairo University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: clinical professor

Study Record Dates

• First Submitted: November 11, 2020
• First Posted: November 18, 2020
• Study Start: January 20, 2019
• Primary Completion: June 30, 2020
• Study Completion: August 31, 2020
• Last Updated: November 18, 2020

Record last verified: 2020-11

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)