Acute Renal Injury After Major Elective Non-Cardiac Surgery

Acute Renal Injury Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04600271
• Other study ID #: 2019/747
• Status: Completed
• Start date: June 1, 2019
• Est. completion date: February 1, 2021

Study information

• Verified date: September 2021
• Source: Istanbul University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 425
• Est. completion date: February 1, 2021
• Est. primary completion date: November 1, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Acute Kidney Injury
• Acute Renal Injury
• Wounds and Injuries

Intervention

Drug:
• Crystalloid Solutions
exposure
• Colloid Blood Volume Expanders
exposure

Other:
• blood replacement
exposure

Drug:
• Diuretic
exposure
• noradrenaline
exposure
• Non-Steroidal Anti-Inflammatory Analgesics
exposure

Locations

Country	Name	City	State
Turkey	Istanbul University Istanbul Faculty of Medicine Departmant of Anesthesiology and Reanimation	Istanbul

Sponsors (1)

Lead Sponsor	Collaborator
Istanbul University

Country where clinical trial is conducted

Turkey, 

References & Publications (3)

Goren O, Matot I. Perioperative acute kidney injury. Br J Anaesth. 2015 Dec;115 Suppl 2:ii3-14. doi: 10.1093/bja/aev380. Review. — View Citation

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. Review. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Acute renal injury	Acute renal injury description will be made with KDIGO criteria.	48 hours
Secondary	Hospital stay	Will be noted as days.	30-90 days
Secondary	ICU stay	Will be noted as days.	30-90 days
Secondary	Chronic Kidney Disease	will be noted after postoperative period.	up to 1 year
Secondary	Mortality	will be noted in the hospital period.	30-90 days
Secondary	Complication after surgery	will be noted in the hospital period.	30-90 days