Assessment of Acute Kidney Injury as a Risk Factor for Myocardial Injury After Non Cardiac Surgery in Critical Patients (clinical audit)

April 26, 2017 updated by: Ghada Safwat, Assiut University
Acute kidney injury (AKI) affects approximately 20% of hospitalized patients and up to 67% of those admitted to an intensive care unit (ICU), making it among the most common organ dysfunctions among the critically ill.Major adverse cardiac events (MACE) after non cardiac surgery are a leading cause of morbidity and mortality. The reported incidence of postoperative myocardial infarction (POMI) among patients undergoing noncardiac surgery is between 3% and 6%.The aim of this study is to Identify the impact of acute kidney injury on the development of myocardial injury after non cardiac surgery and to correlate it with other risk factors of for MINS.

Study Overview

Detailed Description

Acute kidney injury (AKI) is classically described as an abrupt or rapidly reversible reduction in the excretion of nitrogenous waste products, including urea, nitrogen, and creatinine. Acute kidney injury (AKI) affects approximately 20% of hospitalized patients and up to 67% of those admitted to an intensive care unit (ICU), making it among the most common organ dysfunctions among the critically ill. Depending on severity, AKI contributes to short-term mortality rates between 40% and 70%, and survivors are at increased risk for chronic kidney disease. Because surgical care and perioperative events and comorbidities interact to contribute to renal dysfunction in different patterns than in nonsurgical patients, surgical patients have unique risk factors for renal dysfunction.

Major adverse cardiac events (MACE) after non cardiac surgery are a leading cause of morbidity and mortality. The reported incidence of postoperative myocardial infarction (POMI) among patients undergoing noncardiac surgery is between 3% and 6%. Early recognition and timely treatment of POMI after surgery are very important. Therefore, routinemonitoring of cardiac troponin has been recommended to identify patients at risk of early postoperative cardiovascular events after surgery. Myocardial injury after noncardiac surgery (MINS) is defined as follows: myocardial injury caused by ischemia (that may or may not result in necrosis), has prognostic relevance, and occurs duringor within 30 days after noncardiac surgery. MINS can be measured by postoperative troponin elevation in the presence or absence of clinical symptoms. MINS occurs in 8% to 22% of adults undergoing major non cardiacsurgery. To date, there have been few studies investigatingthe risk factors of MINS in critical patients.

The postoperative AKI is a new risk factor of MINS in critical patients, and the impact of AKI on MINS has not been evaluated in previous studies.

It is unclear by what mechanisms AKI influences theMINS in critical patients. A possible explanation of this finding is that in patientswith postoperativeAKI, disturbed autonomic nerve functions may induce postoperative hypotension and hypoperfusion, which may lead to MINS .

Other idependent risk factors for myocardial injury after non cardiac surgery such as emergency surgery and long time operation.The aim of this study is to Identify the impact of acute kidney injury on the development of myocardial injury after non cardiac surgery and to correlate it with other risk factors of for MINS.

Study Type

Observational

Enrollment (Anticipated)

50

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

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

adult above 18 years undergoe non cardiac surgery

Description

Inclusion Criteria:

  • -All patients aged 18 years or more undergoing non cardiac surgery under general or spinal anesthesia and expected length of postoperative hospital stay of at least 48 hour.

Exclusion Criteria:

  • -Pregnancy
  • Perioperative myocardial injury caused by a documented nonischemic etiology (eg, pulmonary embolism, sepsis, cardio version),
  • Heart failure NYHA class III and IV.

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
Assessment of Acute Kidney Injury as a Risk Factor for Myocardial Injury after non Cardiac Surgery in Critical Patients
Time Frame: one year
assessment of a risk factor
one year

Collaborators and Investigators

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

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)

June 1, 2017

Primary Completion (Anticipated)

June 1, 2018

Study Completion (Anticipated)

June 1, 2018

Study Registration Dates

First Submitted

April 26, 2017

First Submitted That Met QC Criteria

April 26, 2017

First Posted (Actual)

May 1, 2017

Study Record Updates

Last Update Posted (Actual)

May 1, 2017

Last Update Submitted That Met QC Criteria

April 26, 2017

Last Verified

April 1, 2017

More Information

Terms related to this study

Other Study ID Numbers

  • Assiut university1711

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

IPD Plan Description

adult above 18years admitted to assiut university hospital intensive care units after non 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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