Assesse Prevalence of Acute Kidney Injury and Myocardial Injury After Non Cardiac Surgeryclinical auditNCT03135483
Assessment of Acute Kidney Injury as a Risk Factor for Myocardial Injury After Non Cardiac Surgery in Critical Patients
An observational study of Assesse Prevalence of Acute Kidney Injury and Myocardial Injury After Non Cardiac Surgery, run by Assiut University.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Assesse Prevalence of Acute Kidney Injury and Myocardial Injury After Non Cardiac Surgery
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- 1 Jun 2017to 1 Jun 2018
- How long will I take part?
- 12 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older adult
Study population: adult above 18 years undergoe non cardiac surgery
Who may be able to join
- -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.
Who cannot join
- -Pregnancy
- Perioperative myocardial injury caused by a documented nonischemic etiology (eg, pulmonary embolism, sepsis, cardio version),
- Heart failure NYHA class III and IV.
About this study
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.
Read the 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.
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of Acute Kidney Injury as a Risk Factor for Myocardial Injury after non Cardiac Surgery in Critical Patients
assessment of a risk factor
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 May 2017
- Study start1 Jun 2017 (estimated)
- Primary completion1 Jun 2018 (estimated)
- Study completion1 Jun 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Assesse Prevalence of Acute Kidney Injury and Myocardial Injury After Non Cardiac SurgeryStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
- Target duration
- 12 Months
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ghada Safwat, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03135483
- Sponsor's protocol ID
- Assiut university1711
- Acronym
- clinical audit
- Status last verified
- Apr 2017
- First submitted
- 26 Apr 2017
- Last updated
- 1 May 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: adult above 18years admitted to assiut university hospital intensive care units after non cardiac surgery
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Acute Kidney Injury as a Risk Factor for Myocardial Injury After Non Cardiac Surgery in Critical Patients
- ClinicalTrials.gov ID
- NCT03135483
- Acronym / sponsor ID
- clinical audit / Assiut university1711
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Jun 2017 (estimated)
- Primary completion
- 1 Jun 2018 (estimated)
- Study completion
- 1 Jun 2018 (estimated)
- First posted
- 1 May 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 12 Months
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- adult above 18 years undergoe non cardiac surgery
Key inclusion criteria (1 listed)
- -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.
Key exclusion criteria (3 listed)
- -Pregnancy
- Perioperative myocardial injury caused by a documented nonischemic etiology (eg, pulmonary embolism, sepsis, cardio version),
- Heart failure NYHA class III and IV.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 May 2017.
- Individual participant dataSharing planned: Undecided. adult above 18years admitted to assiut university hospital intensive care units after non cardiac surgery
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Assesse Prevalence of Acute Kidney Injury and Myocardial Injury After Non Cardiac Surgery, run by Assiut University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 1 May 2017. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assessment of Acute Kidney Injury as a Risk Factor for Myocardial Injury after non Cardiac Surgery in Critical Patients (time frame: one year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 May 2017.