to evaluate the correlation between renal oxygen saturation and acute kidney injury during adult cardiac surgery

A randomised control trial to evaluate renal oxygen saturation as a guide to altered renal perfusion in adult cardiac surgery patients.

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2020/10/028717

Enrollment

Registered

2020-10-29

Start date

Unknown

Completion date

Unknown

Last updated

2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: I251- Atherosclerotic heart disease of native coronary artery Health Condition 2: I05-I09- Chronic rheumatic heart diseases Health Condition 3: Q239- Congenital malformation of aorticand mitral valves, unspecified Health Condition 4: I34- Nonrheumatic mitral valve disorders Health Condition 5: I058- Other rheumatic mitral valve diseases Health Condition 6: I051- Rheumatic mitral insufficiency Health Condition 7: I050- Rheumatic mitral stenosis Health Condition 8: I052- Rheuma

Interventions

Intervention1: adult cardiac surgical patients: in the â??interventionâ?? arm, an intervention will be instituted, as soon as a fall in renal rSO2 will be seen below values of 20% from the baseline

in the following sequence: 1. Vasopressors ( Phenylephrine boluses or Noradrenaline infusion ) or 2. Increasing pump flow to maintain MAP 60 mm Hg or 3. Blood transfusion to keep hematocrit 25% 4. I

Eligibility

Inclusion criteria

Inclusion criteria: Patients in the age group of 18 to 60 years of age, of either sex ASA II - III patients Patients posted for elective cardiac surgery including CABG, valve surgery, combined CABG and valve surgery, under cardiopulmonary bypass Patients willing to give informed and written consent

Exclusion criteria

Exclusion criteria: Patients refusal Emergency surgery Aortic surgery Preoperative renal dysfunction, defined as S.Cr > 1.5mg/dl or end-stage renal disease Preoperative low cardiac output state, defined as Left Ventricle Ejection Fraction ( LVEF ) Body Mass Index ( BMI ) > 30kg/m2 Post renal transplant status Off pump coronary artery bypass grafting surgery Skin to renal capsule distance > 40 mm

Design outcomes

Primary

Measure	Time frame
To assess the efficacy of intervention based on renal rSO2 monitoring in prevention of AKI in post operative period in elective adult cardiac surgical patientsTimepoint: renal saturation monitoring will be done intraoperatively and efficacy of the intervention will be assessed by measuring serum creatinine postoperatively for 2 days	—

Secondary

Measure	Time frame
1.To assess the change in renal rSO2 during intra-operative period as predictor of change in serum creatinine in post-operative period in elective adult cardiac surgical patients. 2.To determine the change in eGFR 3.Mean Duration Of Mechanical Ventilation 4.Mean Duration of ICU stay 5.In Hospital Mortality, in first 48 hours postoperative period 6.Incidence of renal replacement therapy in first 48 hours postoperative periodTimepoint: 1 year	—

Measure

Time frame

1.To assess the change in renal rSO2 during intra-operative period as predictor of change in serum creatinine in post-operative period in elective adult cardiac surgical patients. 2.To determine the change in eGFR 3.Mean Duration Of Mechanical Ventilation 4.Mean Duration of ICU stay 5.In Hospital Mortality, in first 48 hours postoperative period 6.Incidence of renal replacement therapy in first 48 hours postoperative periodTimepoint: 1 year

—

Countries

India

Contacts

Public ContactRicha Malik

AIIMS Rishikesh

ajaymishra0701@gmail.com9340482058

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026