Acute Kidney Injury After Cardiac Surgery

October 14, 2021 updated by: Omar Arafat Sadek Sayed, Assiut University

Acute Kidney Injury After Cardiac Surgery in Patients Without Chronic Kidney Disease.

The study aims to identify the Following: -

  1. incidence and mortality of cardiac Surgery associated -AKI based on the new consensus diagnostic systems of KDIGO (Kidney Disease Improving Global Outcomes).
  2. use of biomarkers for the early detection of clinical and subclinical cardiac Surgery associated-AKI.
  3. risk factors and prediction models of cardiac Surgery associated-AKI.
  4. optimal cardiac surgical procedures including conventional versus minimally invasive approaches, on-pump versus off-pump, and optimal management of cardiac surgical support including duration of CPB, perfusion pressure, hemodilution, and hypothermia during CPB.
  5. controversial pharmacologic therapies for the prevention and treatment of cardiac Surgery associated-AKI including statins, sodium bicarbonate, and N-acetylcysteine (NAC).

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

Acute renal injury (AKI) is a severe complication that occurs in 3.5-31.0% of patients undergoing cardiac surgery, making it one of the most common complications observed in this group of patients.

Evidence suggests that even slight postoperative increases in serum creatinine levels are associated with a significant increase in the risk of death. Among individuals undergoing cardiac surgery, mortality has been reported to be as high as 8% and postoperative AKI can increase the mortality rate to over 60%. The occurrence of AKI in patients undergoing cardiac surgery raises the mortality rate from 0.4-4.4% to 1.3-22.3%; when those same patients require dialysis, rates range from 25% to 88.9%, making severe postoperative AKI an independent risk factor for mortality that results in an 8-fold increase in the risk of death. Therefore, cardiac surgery AKI is associated with serious complications as well as with prolonged intensive care unit (ICU) stays and with a worse quality of life. It also increases early and late mortality and health care expenditures.

The early identification of patients at risk of developing AKI after cardiac surgery is an important strategy for improving the care of such patients during the intraoperative and postoperative periods. Many factors have been found to facilitate the development of AKI after cardiac surgery such as: age; obesity; female gender; valve replacement surgery; myocardial infarction in the last 30 days; low cardiac output; blood transfusion; and many others.

Epidemiological studies of AKI in cardiac surgery patients are important because they allow for better diagnosis of AKI and facilitate the prognosis estimation, as well as the development of new, more effective strategies to prevent and minimize this complication, thus reducing the associated morbidity and mortality.

Study Type

Observational

Enrollment (Anticipated)

200

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

  • Name: Mohamed A Khalil Salama Ayyad, Professor
  • Phone Number: +201002001932
  • Email: makayyad@aun.edu.eg

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

All patients between 18 and 80 years of age who will undergo cardiac surgery, between 2021 and 2024, except those mentioned in exclusion criteria. All the procedures will be performed at a tertiary care cardiac hospital that serves the public and private sector.

Description

Inclusion Criteria:

  • On-pump cardiac surgery;
  • Off-pump Cardiac Surgery;
  • Informed and written consent of the patient or inclusion according to the emergency procedure;
  • Affiliated patient or beneficiary of a social protection.

Exclusion Criteria:

  • Patients who underwent cardiac surgery for congenital heart disease.
  • Patients who underwent emergency heart surgery.
  • patients who, within the last 72 hours before surgery, were injected with iodinated contrast (because of its potential nephrotoxicity).
  • patients with chronic Kidney disease. 5- patients with a preoperative serum creatinine >2 mg/dL.
  • patients who died within the first 24 hours after surgery.
  • patients on mechanical ventilation before intervention.
  • Patients with preoperative medical disorders other than cardiac affection.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The early identification of patients at risk of developing AKI after cardiac surgery
Time Frame: Baseline
observing if The early identification of patients at risk of developing AKI after cardiac surgery will or will not affect the postoperative Mortality.
Baseline

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
ICU and hospital Length of stay
Time Frame: Baseline
observing if the patients which will develop AKI after cardiac surgery will or will not affect their ICU and hospital Length of stay.
Baseline
Vent days
Time Frame: Baseline
observing if the patients which will develop AKI after cardiac surgery will or will not affect their need for and the Period of Mechanical ventilation.
Baseline
The need for renal replacement therapy
Time Frame: Baseline
observing if the patients which will develop AKI after cardiac surgery will or will not become in need for renal replacement therapy.
Baseline
Renal recovery
Time Frame: Baseline
observing the relation between developing AKI after cardiac surgery and Renal recovery.
Baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assiut University

Investigators

  • Principal Investigator: Omar A Sadek, M.Sc., Assiut University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

November 1, 2021

Primary Completion (Anticipated)

October 1, 2024

Study Completion (Anticipated)

November 1, 2024

Study Registration Dates

First Submitted

September 30, 2021

First Submitted That Met QC Criteria

October 4, 2021

First Posted (Actual)

October 15, 2021

Study Record Updates

Last Update Posted (Actual)

October 19, 2021

Last Update Submitted That Met QC Criteria

October 14, 2021

Last Verified

October 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AKIN and Cardiac Surgery

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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