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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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04600271
Enrollment
425
Registered
2020-10-23
Start date
2019-06-01
Completion date
2021-02-01
Last updated
2021-09-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Renal Injury

Keywords

colloids, mean arterial blood pressure

Brief summary

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.

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.

Interventions

DRUGColloid Blood Volume Expanders

exposure

OTHERblood replacement

exposure

exposure

exposure

DRUGNon-Steroidal Anti-Inflammatory Analgesics

exposure

Sponsors

Istanbul University
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Acute renal injury48 hoursAcute renal injury description will be made with KDIGO criteria.

Secondary

MeasureTime frameDescription
Hospital stay30-90 daysWill be noted as days.
ICU stay30-90 daysWill be noted as days.
Chronic Kidney Diseaseup to 1 yearwill be noted after postoperative period.
Mortality30-90 dayswill be noted in the hospital period.
Complication after surgery30-90 dayswill be noted in the hospital period.

Countries

Turkey (Türkiye)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026