Foley Catheters for Acute Kidney Injury

Overseen By Phat T Dang, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Dang Tan Phat

Disqualifiers: Pregnancy, ESRD, AKI, ECMO, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: Perioperative period

100 Participants Needed

Trial Summary

What is the purpose of this trial?

The goal of this clinical trial is to determine whether monitoring intra-abdominal pressure (IAP) and adjusting blood pressure accordingly to maintain optimal renal perfusion pressure can reduce the risk of acute kidney injury (AKI) after cardiac surgery. The main question this study aims to answer is: - Does IAP-guided blood pressure management improve renal perfusion and lower AKI rates in cardiac surgery patients? Participants will be randomly assigned to one of two groups: * Control Group: Standard ICU care with a conventional Foley catheter. * Intervention Group: Standard ICU care with an IAP-monitoring Foley catheter, where blood pressure is adjusted based on IAP readings to optimize renal perfusion pressure. All participants will undergo routine blood and urine tests to assess kidney function during their hospital stay. This study will help determine whether IAP-based hemodynamic management can improve postoperative kidney outcomes and provide a new strategy for AKI prevention in cardiac surgery patients.

Eligibility Criteria

This trial is for cardiac surgery patients at risk of acute kidney injury (AKI). It's open to those who can have their blood pressure managed based on intra-abdominal pressure readings. Details about specific inclusion and exclusion criteria are not provided.

Inclusion Criteria

I am an adult scheduled for heart surgery using a heart-lung machine.

Left ventricular ejection fraction (LVEF) < 50%

Exclusion Criteria

Current pregnancy

I need surgery urgently.

I am on dialysis for end-stage kidney disease or acute kidney injury.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants receive standard ICU care with either a conventional or IAP-monitoring Foley catheter after cardiac surgery. Blood pressure is adjusted based on IAP readings for the intervention group.

Perioperative period

Continuous monitoring during hospital stay

Follow-up

Participants are monitored for safety and effectiveness after treatment, focusing on kidney function and incidence of AKI.

Until hospital discharge

Treatment Details

Interventions

• IAP-guided Blood Pressure Management

Trial Overview The study compares two groups: one with standard ICU care using a conventional Foley catheter, and another with an IAP-monitoring Foley catheter adjusting blood pressure to optimize kidney perfusion. The goal is to see if this reduces AKI after surgery.

Participant Groups

Group I: Intervention Group - IAP Monitoring and Renal Perfusion Pressure Optimization Experimental Treatment 1 Intervention

Participants will receive standard ICU care after cardiac surgery with an IAP-monitoring Foley catheter. Blood pressure will be adjusted based on IAP readings to optimize renal perfusion pressure(41mmHg).

Group II: Control Group - Standard ICU Care with Conventional Foley Active Control 1 Intervention

Participants will receive standard ICU care after cardiac surgery with a conventional Foley catheter. Blood pressure management will follow routine ICU protocols without intra-abdominal pressure (IAP) monitoring.

Who Is Running the Clinical Trial?

Dang Tan Phat

Lead Sponsor