Acute Renal Injury After Major Elective Non-Cardiac Surgery

September 15, 2021 updated by: Dilan Büyük, Istanbul University

Risk Factors of Acute Kidney Injury After Major Elective Non-Cardiac Surgery : A Prospective Observational Study

The study is planned to be a single-center study and includes patients who underwent major surgery within Istanbul University Istanbul Faculty of Medicine with an invasive arterial line. Our aim to define the incidence of acute renal injury in our setting and to investigate the risk factors listed in detailed description. After obtaining written informed consent from the patients, preoperative risk factors will be notes. Following standard anesthesia monitoring as well as routine anesthesia induction and maintenance, invasive arterial monitoring will be performed due to the major surgery and hemodynamic values will be recorded throughout the surgery. The primary outcome will be acute renal injury based on KDIGO's (Kidney Disease: Improving Global Outcomes) definition of acute renal damage. Postoperative data regarding this outcome as well as additional data listed in detailed description will be collected.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

The study is a single-center study that observes patients who undergo major abdominal surgery within Istanbul University Istanbul Faculty of Medicine.

Standard anesthesia monitoring (NIBP, SPO2(oxygen saturation by pulse oximetry), ECG) will be applied to the patients taken to the operation room. Routine anesthesia induction and maintenance will be performed by the anesthetist responsible for the patients. After anesthesia induction, invasive arterial monitoring will be performed.

Our data collection and recording will be as follows: preoperative, intraoperative, postoperative.

In the preoperative section;

  • Age, gender, height, weight, BMI of the patient
  • ASA (American Society of Anesthesiologists) classification, additional diseases and functional capacity
  • Drugs used (ACE-İ, ARB (angiotensin receptor blocker), Statin, B-blocker, NSAID)
  • Entry creatinine and eGFR (estimated glomerular filtration rate) calculated with CKD-EPI (Chronic Kidney Disease Epidemiology Collaboration)
  • Entry hemoglobin, lymphocyte, CRP (C reactive protein)
  • The presence of ascites in the abdomen

In the intraoperative section;

  • Surgery (gynecological oncology surgery, gastrointestinal surgery, genitourinary surgery) and its duration
  • Applied form of anesthesia (general-regional)
  • Liquids given during the operation (Crystalloid (isotonic, isolyte, lactated ringer), colloid, albumin) and their amounts oNoradrenaline requirement
  • Use of diuretic, NSAID
  • Blood transfusion
  • Total amount of bleeding during the operation
  • First arterial blood gas electrolytes taken due to routine major surgery
  • The lowest amount of hemoglobin seen during the operation
  • Routine invasive artery monitorization due to major surgery, and mean arterial pressure In the postoperative section;
  • Requirement of intensive care
  • Blood transfusion requirement
  • Noradrenaline requirement
  • Use of diuretic and NSAID
  • Electrolyte values in the first blood gas taken routinely
  • Creatinine value immediately after the surgery and at 24th and 48th hours
  • First 48-hour urine output The diagnosis of acute renal injury is based on KDIGO's definition of acute renal damage. By analyzing from this information, significant risk factors for acute renal damage are identified and measures are taken against them.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
425

Contacts and Locations

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

Study Locations

  • Turkey
      • Istanbul, Turkey, 34093
        • Istanbul University Istanbul Faculty of Medicine Departmant of Anesthesiology and Reanimation

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients who have undergone non-cardiac major surgery in Istanbul University Faculty of Medicine will be included in the study.

Description

Inclusion Criteria:

  • Age of ≥18 years
  • Patients who are ASA I-III
  • Patients who have undergone major noncardiac surgery
  • Patients who need post-operative intensive care follow-up due to major surgery or long surgery
  • Patients diagnosed with CKD but do not need routine hemodialysis

Exclusion Criteria:

  • Age of <18 years
  • Patients who have undergone minor surgery
  • Surgeries which lasts <30 minutes
  • Patients who will be hospitalized less than two days postoperatively
  • Patients who need routine hemodialysis due to CKD
  • Patients who had renal transplantation

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

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Study Group
Patients over the age of 18 and who undergone major elective non-cardiac abdominal surgery.
Drug: Crystalloid Solutions
exposure
Drug: Colloid Blood Volume Expanders
exposure
Other: blood replacement
exposure
Drug: Diuretic
exposure
Drug: noradrenaline
exposure
Drug: Non-Steroidal Anti-Inflammatory Analgesics
exposure

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Acute renal injury
Time Frame: 48 hours
Acute renal injury description will be made with KDIGO criteria.
48 hours

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Hospital stay
Time Frame: 30-90 days
Will be noted as days.
30-90 days
ICU stay
Time Frame: 30-90 days
Will be noted as days.
30-90 days
Chronic Kidney Disease
Time Frame: up to 1 year
will be noted after postoperative period.
up to 1 year
Mortality
Time Frame: 30-90 days
will be noted in the hospital period.
30-90 days
Complication after surgery
Time Frame: 30-90 days
will be noted in the hospital period.
30-90 days

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Istanbul University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Mukadder Orhun Sungur, Assos. Prof., Istanbul 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 (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 1, 2019

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 1, 2020

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 1, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 11, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 19, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 23, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 22, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 15, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2019/747

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

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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