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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial investigates whether monitoring intra-abdominal pressure (IAP) and adjusting blood pressure based on those readings can prevent kidney problems after heart surgery. Participants will join one of two groups: one receiving standard ICU care with a regular catheter, and another using a special catheter that monitors IAP to guide blood pressure management (IAP-guided Blood Pressure Management). This approach aims to enhance blood flow to the kidneys and reduce the risk of acute kidney injury (AKI). The trial may suit individuals undergoing heart surgery with a heart pump and a heart function measure (left ventricular ejection fraction) below 50%. As an unphased trial, it offers a unique opportunity to contribute to innovative research that could improve post-surgical outcomes.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that this IAP-monitoring Foley catheter is safe for cardiac surgery patients?

Research shows that checking intra-abdominal pressure (IAP) is generally safe for patients. Studies suggest that using IAP to manage blood pressure can prevent kidney problems after surgery. Although exact safety numbers are unavailable, the goal is to maintain steady blood flow to the kidneys, reducing the risk of sudden kidney issues.

This trial uses a special type of Foley catheter to measure IAP, differing slightly from the standard hospital catheter. It helps doctors adjust blood pressure to protect the kidneys. So far, research has not identified any major safety concerns with this method, and patients in other studies have tolerated it well.

In summary, the IAP-guided blood pressure management being tested aims to improve kidney health after surgery without adding significant risk. Previous research supports the safety of this treatment, even if exact safety numbers are not available. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores a novel approach to managing blood pressure in patients with acute kidney injury after cardiac surgery. Unlike standard care, which relies on routine blood pressure management, this method uses a Foley catheter to monitor intra-abdominal pressure (IAP) and adjust blood pressure to optimize renal perfusion pressure. This could potentially improve kidney function by ensuring the kidneys receive adequate blood flow, which is crucial for recovery. The trial aims to provide insights that could lead to more personalized and effective treatment strategies for acute kidney injury.

What evidence suggests that IAP-guided blood pressure management is effective for reducing acute kidney injury?

This trial will compare two approaches for managing blood pressure in patients after cardiac surgery. Research has shown that monitoring intra-abdominal pressure (IAP) can help manage blood pressure in a way that benefits the kidneys. Participants in the intervention group will receive IAP-guided blood pressure management, adjusting blood pressure based on IAP readings to optimize renal perfusion pressure. One study found that high pressure in this area is linked to a higher risk of sudden kidney problems. By measuring this pressure, doctors can adjust blood pressure to ensure the kidneys receive enough blood. This method may help prevent kidney issues after surgeries, like heart operations. Early results suggest that using this pressure-guided approach might reduce the risk of kidney problems, offering a promising way to protect kidney health during recovery. Meanwhile, the control group will receive standard ICU care with conventional Foley catheters, following routine ICU protocols without IAP monitoring. ^{1 6 7 8 9}

Are You a Good Fit for This Trial?

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.

Currently on ECMO or Impella

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06989762

Intraabdominal Pressure Monitoring Urinary Catheter and ... This study will help determine whether IAP-based hemodynamic management can improve postoperative kidney outcomes and provide a new strategy for AKI prevention ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8168038/

Intra-abdominal hypertension and increased acute kidney ... The present meta-analysis aimed to determine the relationship between intra-abdominal hypertension (IAH) and an increased prevalence of acute kidney injury (AKI) ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12351976/

Relationship between intra-bladder pressure and acute ... Measuring intra-abdominal pressure (IAP) is very important for the management of patients with AP, and intra-bladder pressure (IBP) is an ...

4. sciencedirect.com sciencedirect.com/science/article/pii/S1008127524001524

Relevance of intra-abdominal pressure monitoring in non- ... The study aimed to find any correlation between clinical parameters and IAP, and their effect on the NOM of patients with blunt liver and splenic injury.

5. mdpi.com mdpi.com/1648-9144/61/3/383

Acute Kidney Injury Secondary to Abdominal Compartment ... This study investigates the association between intra-abdominal pressure (IAP) changes, renal biomarkers, and mortality in patients with ACS-related AKI.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11943739/

Acute Kidney Injury Secondary to Abdominal Compartment ... This study investigates the association between intra-abdominal pressure (IAP) changes, renal biomarkers, and mortality in patients with ACS-related AKI.

7. journals.sagepub.com journals.sagepub.com/doi/10.1177/03000605211016627

Intra-abdominal hypertension and increased acute kidney ... The present meta-analysis aimed to determine the relationship between intra-abdominal hypertension (IAH) and an increased prevalence of acute kidney injury ...

8. tandfonline.com tandfonline.com/doi/full/10.3109/0886022X.2013.876353

Intra-abdominal pressure as a predictor of acute kidney ... Results: A total of 60 patients were evaluated, 16 patients developed intra-abdominal hypertension (IAH), 45 developed an abnormal IAP (>7 mmHg) and 26 ...

9. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5885226/

Acute kidney injury and intra-abdominal hypertension in ... To evaluate the frequency of intra-abdominal hypertension in major burn patients and its association with the occurrence of acute kidney injury.