Acute Renal Injury After Major Elective Non-Cardiac Surgery

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: Completed
• Conditions: Acute Renal Injury
• Intervention / Treatment: Drug: Crystalloid Solutions; Drug: Colloid Blood Volume Expanders; Other: blood replacement; Drug: Diuretic; Drug: noradrenaline; Drug: Non-Steroidal Anti-Inflammatory Analgesics

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: Observational
• Enrollment (Actual): 425

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• 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

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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

Outcome Measure	Measure Description	Time Frame
Acute renal injury	Acute renal injury description will be made with KDIGO criteria.	48 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Hospital stay	Will be noted as days.	30-90 days
ICU stay	Will be noted as days.	30-90 days
Chronic Kidney Disease	will be noted after postoperative period.	up to 1 year
Mortality	will be noted in the hospital period.	30-90 days
Complication after surgery	will be noted in the hospital period.	30-90 days

Collaborators and Investigators

• Sponsor: Istanbul University
• Investigators: Study Director: Mukadder Orhun Sungur, Assos. Prof., Istanbul University

Publications and helpful links

General Publications

• Hobson C, Ruchi R, Bihorac A. Perioperative Acute Kidney Injury: Risk Factors and Predictive Strategies. Crit Care Clin. 2017 Apr;33(2):379-396. doi: 10.1016/j.ccc.2016.12.008.
• Goren O, Matot I. Perioperative acute kidney injury. Br J Anaesth. 2015 Dec;115 Suppl 2:ii3-14. doi: 10.1093/bja/aev380.
• Sun LY, Wijeysundera DN, Tait GA, Beattie WS. Association of intraoperative hypotension with acute kidney injury after elective noncardiac surgery. Anesthesiology. 2015 Sep;123(3):515-23. doi: 10.1097/ALN.0000000000000765.

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2019
• Primary Completion (Actual): November 1, 2020
• Study Completion (Actual): February 1, 2021

Study Registration Dates

• First Submitted: October 11, 2020
• First Submitted That Met QC Criteria: October 19, 2020
• First Posted (Actual): October 23, 2020

Study Record Updates

• Last Update Posted (Actual): September 22, 2021
• Last Update Submitted That Met QC Criteria: September 15, 2021
• Last Verified: September 1, 2021

More Information

Terms related to this study

• Keywords: colloids; mean arterial blood pressure
• Additional Relevant MeSH Terms: Kidney Diseases; Urologic Diseases; Renal Insufficiency; Wounds and Injuries; Acute Kidney Injury; Physiological Effects of Drugs; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Autonomic Agents; Peripheral Nervous System Agents; Sensory System Agents; Analgesics, Non-Narcotic; Antirheumatic Agents; Adrenergic alpha-Agonists; Adrenergic Agonists; Natriuretic Agents; Sympathomimetics; Vasoconstrictor Agents; Anti-Inflammatory Agents; Norepinephrine; Anti-Inflammatory Agents, Non-Steroidal; Analgesics; Diuretics
• Other Study ID 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