Acute Renal Injury After Major Elective Non-Cardiac Surgery

Completed

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

• Registration Number: NCT04600271
• Lead Sponsor: Istanbul University

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.

Study Timeline

• Study Start: 2019-06-01
• Study First Submitted: 2020-10-11
• Study First Submitted QC: 2020-10-19
• Study First Posted: 2020-10-23
• Primary Completion: 2020-11-01
• Study Completion: 2021-02-01
• Status Verified: 2021-09
• Last Update Submitted: 2021-09-15
• Last Update Posted: 2021-09-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 425

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Study Group	blood replacement	Patients over the age of 18 and who undergone major elective non-cardiac abdominal surgery.
Study Group	Non-Steroidal Anti-Inflammatory Analgesics	Patients over the age of 18 and who undergone major elective non-cardiac abdominal surgery.
Study Group	Colloid Blood Volume Expanders	Patients over the age of 18 and who undergone major elective non-cardiac abdominal surgery.
Study Group	Crystalloid Solutions	Patients over the age of 18 and who undergone major elective non-cardiac abdominal surgery.
Study Group	noradrenaline	Patients over the age of 18 and who undergone major elective non-cardiac abdominal surgery.
Study Group	Diuretic	Patients over the age of 18 and who undergone major elective non-cardiac abdominal surgery.

Primary Outcome Measures

Name	Time	Method
Acute renal injury	48 hours	Acute renal injury description will be made with KDIGO criteria.

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Istanbul University Istanbul Faculty of Medicine Departmant of Anesthesiology and Reanimation; 🇹🇷 Istanbul, Turkey