Acute Kidney Damage in Patients Undergoing Open Heart Surgery

NCT05426291 | Completed

• 1 other identifier: SadiKonuk
• Study Type: observational
• Target: 88
• Locations: 1 country
• Sites: 1

Brief Summary

Aimed to determine whether preoperative biomarkers (Mg, Hgb, CRP, ProBNP) would be helpful in the early diagnosis of CSA-AKI (cardiac surgery-related acute kidney injury) in patients undergoing open heart surgery.

Conditions

Kidney Injury, Acute

Keywords

Open Heart Surgery

Outcome Measures

Primary Outcomes (2)

• The requirement of continue venovenous hemodiafiltration (CVVHDF)

  After on pump surgery resulting AKI may require CVVHDF(pH\<7.21, urine output \< 0.5 ml/kg during 6 hours, potassium \> 6 mEq/L)

  Immediately after surgery

• Predict acute renal failure in on-pomp conary artery bypass via preoperative biomarkers

  To detect acute kidney injury in the early period in open heart surgery and to take precautions

  up to postoperative 28th day

Secondary Outcomes (1)

• The requirement of hemodialysis during postoperative 28 days

  up to postoperative 28th day

Study Arms (2)

Group I

At least two of the preoperative biomarkers (Mg\<0.85 mmol/L, Hgb\<8.5 mmol/L, proBNP\>480 pg/mL, CRP\>5 mg/L) that are thought to be closely related to acute kidney injury after cardiac surgery Group I,

Other: BIOMARKER LEVELS IS IT POSSIBLE TO PREDICT ACUTE RENAL DAMAGE IN THE PREOP PERIOD?

Group II

Patients who meet at least two of the preoperative biomarkers (Mg\>0.85 mmol/L, Hgb\>8.5 mmol/L, proBNP\<480 pg/mL, CRP\<5 mg/L) Group II .

Other: BIOMARKER LEVELS IS IT POSSIBLE TO PREDICT ACUTE RENAL DAMAGE IN THE PREOP PERIOD?

Interventions

BIOMARKER LEVELS IS IT POSSIBLE TO PREDICT ACUTE RENAL DAMAGE IN THE PREOP PERIOD? OTHER

In open heart surgery, it will be followed whether acute kidney injury will develop by looking at the biomarkers in the preoperative period.

Group I; Group II

Eligibility Criteria

• Age: 40 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Adult patients (aged ≥40 years,\<85 years) with ASA II-IV who were scheduled for elective open heart surgery under cardiopulmonary bypass (CPB) will be prospectively included in this study. Patients included in the study will be divided into two groups. At least two of the preoperative biomarkers (Mg\<0.85 mmol/L, Hgb\<8.5 mmol/L, proBNP\>480 pg/mL, CRP\>5 mg/L) that are thought to be closely related to acute kidney injury after cardiac surgery Group I, patients who meet at least two of the preoperative biomarkers (Mg\>0.85 mmol/L, Hgb\>8.5 mmol/L, proBNP\<480 pg/mL, CRP\<5 mg/L) Group II will be included in the study.

You may qualify if:

• Elective on-pomp coronary artery bypass

You may not qualify if:

• Emergency operation,
• Off pump coronary artery bypass
• Revision (repetitive) operation
• Preoperative acute Renal failure
• Preoperative chronic Renal failure
• Preoperative decompansed heart failure
• Valve replacement surgery

Sponsors & Collaborators

• Bakirkoy Dr. Sadi Konuk Research and Training Hospital: lead

Study Sites (1)

BakirkoySadiKonuk Training and Searching Hospital

Istanbul, 34147, Turkey (Türkiye)

Location

Related Links

• Associations Between Preoperative Biomarkers and Cardiac Surgery-Associated Acute Kidney Injury in Elderly Patients: A Cohort Study
• Postoperative kidney oxygen saturation as a novel marker for acute kidney injury after adult cardiac surgery

Biospecimen

Retention: SAMPLES WITH DNA

cystatin c level will be checked in the blood sample taken from the patient

MeSH Terms

Conditions

Acute Kidney Injury

Condition Hierarchy (Ancestors)

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

Study Officials

• Gülsüm Oya HERGÜNSEL, Ass. Prof.

  Bakirkoy Dr. Sadi Konuk Research and Training Hospital

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 4 Weeks
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: April 18, 2022
• First Posted: June 21, 2022
• Study Start: September 30, 2022
• Primary Completion: November 30, 2023
• Study Completion: May 30, 2024
• Last Updated: June 17, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)