Acute Renal Injury After Major Elective Non-Cardiac Surgery

NCT04600271 | Completed

• 1 other identifier: 2019/747
• Study Type: observational
• Target: 425
• Locations: 1 country
• Sites: 1

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.

Conditions

Acute Renal Injury

Keywords

colloids; mean arterial blood pressure

Outcome Measures

Primary Outcomes (1)

• Acute renal injury

  Acute renal injury description will be made with KDIGO criteria.

  48 hours

Secondary Outcomes (5)

• Hospital stay

  30-90 days

• ICU stay

  30-90 days

• Chronic Kidney Disease

  up to 1 year

• Mortality

  30-90 days

• Complication after surgery

  30-90 days

Study Arms (1)

Study Group

Patients over the age of 18 and who undergone major elective non-cardiac abdominal surgery.

Drug: Crystalloid Solutions; Drug: Colloid Blood Volume Expanders; Other: blood replacement; Drug: Diuretic; Drug: noradrenaline; Drug: Non-Steroidal Anti-Inflammatory Analgesics

Interventions

Crystalloid Solutions DRUG

exposure

Study Group

Colloid Blood Volume Expanders DRUG

exposure

Study Group

blood replacement OTHER

exposure

Study Group

Diuretic DRUG

exposure

Study Group

noradrenaline DRUG

exposure

Study Group

Non-Steroidal Anti-Inflammatory Analgesics DRUG

exposure

Study Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Istanbul University: lead

Study Sites (1)

Istanbul University Istanbul Faculty of Medicine Departmant of Anesthesiology and Reanimation

Istanbul, 34093, Turkey (Türkiye)

Location

Related Publications (3)

• 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.

  PMID: 28284301 BACKGROUND

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

  PMID: 26658199 BACKGROUND

• 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.

  PMID: 26181335 RESULT

MeSH Terms

Conditions

Acute Kidney Injury

Interventions

Crystalloid Solutions; Diuretics; Norepinephrine; Anti-Inflammatory Agents, Non-Steroidal

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Isotonic Solutions; Solutions; Pharmaceutical Preparations; Natriuretic Agents; Physiological Effects of Drugs; Pharmacologic Actions; Chemical Actions and Uses; Ethanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Amines; Biogenic Monoamines; Biogenic Amines; Catecholamines; Catechols; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Analgesics, Non-Narcotic; Analgesics; Sensory System Agents; Peripheral Nervous System Agents; Anti-Inflammatory Agents; Therapeutic Uses; Antirheumatic Agents

Study Officials

• Mukadder Orhun Sungur, Assos. Prof.

  Istanbul University

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Resident at Anesthesiology and Reanimation

Study Record Dates

• First Submitted: October 11, 2020
• First Posted: October 23, 2020
• Study Start: June 1, 2019
• Primary Completion: November 1, 2020
• Study Completion: February 1, 2021
• Last Updated: September 22, 2021

Record last verified: 2021-09

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)