Acute Renal Injury After Major Elective Non-Cardiac Surgery

Sponsor

Istanbul University (Other)

Overall Status

Completed

CT.gov ID

NCT04600271

Collaborator

(none)

425

Enrollment

Location

20.1

Actual Duration (Months)

21.2

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Acute Renal Injury	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 Design

Study Type:

Observational

Actual Enrollment :

425 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

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

Actual Study Start Date :

Jun 1, 2019

Actual Primary Completion Date :

Nov 1, 2020

Actual Study Completion Date :

Feb 1, 2021

Arms and Interventions

Arm	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

Arm

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

Outcome Measures

Primary Outcome Measures

Acute renal injury [48 hours]
Acute renal injury description will be made with KDIGO criteria.

Secondary Outcome Measures

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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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