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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT03135483
Other study ID # Assiut university1711
Secondary ID
Status Not yet recruiting
Phase N/A
First received April 26, 2017
Last updated April 26, 2017
Start date June 1, 2017
Est. completion date June 1, 2018

Study information

Verified date April 2017
Source Assiut University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial Summary

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.


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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 50
Est. completion date June 1, 2018
Est. primary completion date June 1, 2018
Accepts healthy volunteers
Gender All
Age group 18 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Assiut University

Outcome

Type Measure Description Time frame Safety issue
Primary Assessment of Acute Kidney Injury as a Risk Factor for Myocardial Injury after non Cardiac Surgery in Critical Patients assessment of a risk factor one year