Ann Arbor, MINCT07017933Now EnrollingIRB Ready

Renal Impairment After Cardiac Surgery Clinical Trial in Ann Arbor, MI

Access cutting-edge renal impairment after cardiac surgery treatment through this clinical trial at a research site in Ann Arbor. Study-provided care at no cost to qualified participants.

Sponsored by 3ive Labs

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Expert Care in Ann Arbor

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IRB Approved

This study follows strict safety protocols and ethical guidelines

No-Cost Care

All study-related renal impairment after cardiac surgery treatment provided free

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Check if you qualify for this renal impairment after cardiac surgery clinical trial in Ann Arbor, MI

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Why Participate?

  • No-Cost Study Care

  • Local to Ann Arbor

    Convenient for MI residents

  • Cutting-Edge Treatment

    Access to innovative therapies

  • Expert Medical Care

    Close monitoring by specialists

  • Possible Compensation*

    For time and travel

*Compensation varies by study. Confirm details with coordinator.

Simple Process

  1. 1Submit this form
  2. 2Phone screening
  3. 3Visit Ann Arbor site if eligible
  4. 4Begin participation

About This Renal Impairment After Cardiac Surgery Study in Ann Arbor

Patients with renal insufficiency who undergo cardiac surgery with cardiopulmonary bypass (CPB) are at significant risk for exacerbation of renal dysfunction postoperatively. This in turn is associated with an increased risk of prolonged intensive care unit (ICU) length of stay, other comorbidities including surgical complications and 30-day mortality. Renal impairment is generally identified based on an increase in serum creatinine concentration and/or a certain magnitude decrease in estimated glomerular filtration rate (eGFR). The JuxtaFlow® Renal Assist Device (RAD) is designed to sustain or enhance glomerular filtration perioperatively for patients with renal insufficiency by applying a mild controlled negative pressure to the collecting system via the renal pelvis, thereby increasing effective filtration pressure and reducing tubular pressure. This mechanism is designed to support the kidneys' functions during times of renal stress that would be associated with intrarenal edema, volume overload, increased venous pressure, and inflammatory response. By supporting renal function, specifically during the acute stress of CPB, JuxtaFlow holds promise to protect nephron function, decrease renal hypoxia, and provide multifactorial kidney function support to maintain their ability to manage future stress.

Sponsor: 3ive Labs

Who Can Participate

Inclusion Criteria

To be eligible for participation in this study, an individual must meet all the following criteria:
A candidate for elective or urgent on-pump coronary artery bypass grafting (CABG) and/or valvular surgery
Male or Female age 22 to 85 years
Estimated glomerular filtration rate (eGFR) 15 - 60 mL/min/1.73m2
Signed and dated informed consent
Female patients of childbearing potential must:
have negative pregnancy test at the informed consent visit,
be using previously initiated approved and effective contraception from the informed consent visit through completion of the study \*The only recommended contraception is condoms.

Exclusion Criteria

An individual who meets any of the following criteria will be excluded from participation in this study:
Any individual, or their legally authorized representative (LAR), who does not understand the requests and risks of participating in the clinical trial or is unable to give informed consent
Pregnancy or lactation
Prior cardiac surgery within the last 6 months
Hemodynamic instability as determined by the Principal Investigator
Immunosuppression
Active infections (e.g. HIV, Tbc, and all types of Hepatitis)
History of polycystic kidney disease
Patients with only one active kidney or one poorly functioning kidney
Evidence of current kidney obstruction (e.g., Kidney stones)
Evidence of current hydronephrosis
Active upper and/or lower urinary tract infections
Malignancy; oncological Surgery within 5 years or ongoing antitumoral treatment
Ongoing sepsis or endocarditis
Patients who have an expected 30-day postoperative mortality greater than 10% as determined by the Principal Investigator
Any secondary condition as determined by the investigator that would place the subject at an increased risk or preclude the subject's full compliance with the study procedures, including injuries to the urinary organs and/or external genitals; or severe BPH
Unexplained/unexpected gross hematuria as determined by the Investigator
Current or planned treatment with an investigational drug (IND), device (IDE), or other investigational intervention within 3 months prior to or during participation in this clinical trial
Patients who have a current unrepaired ureteral avulsion as determined by the investigator
Patients otherwise contraindicated for urological interventions, including ureter guidewire placement via bladder cystoscopy and ureteral catheterization, or otherwise contraindicated for any of the other study procedures

Not sure if you qualify? Submit your interest and a study coordinator will help determine your eligibility.

Frequently Asked Questions

Q:Is this study available in Ann Arbor?

Yes, this clinical trial (NCT07017933) has an active research site in Ann Arbor, MI that is currently enrolling participants.

Q:Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. This study has been reviewed and approved, and participants are closely monitored by medical professionals. You can withdraw at any time.

Q:Will I be compensated?

Many clinical trials offer compensation for your time and travel expenses. Specific compensation details will be discussed during the screening process. All study-related medical care is provided at no cost.

Q:Can I leave the trial if I change my mind?

Absolutely. Participation is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty.

Still have questions? Our study coordinators are here to help.

Renal Impairment After Cardiac Surgery Treatment Options in Ann Arbor, MI

If you're searching for renal impairment after cardiac surgery treatment options in Ann Arbor, MI, this clinical trial (NCT07017933) may be an excellent opportunity. Clinical trials provide access to cutting-edge treatments that aren't yet available to the general public, often at no cost to participants.

Our Ann Arbor research site is actively enrolling participants for this clinical trial. You'll receive care from experienced renal impairment after cardiac surgery specialists who are at the forefront of medical research. All study-related care, including examinations, treatments, and monitoring, is provided at no cost to qualified participants.

Looking for more options? Browse all renal impairment after cardiac surgery clinical trials near you to find additional studies recruiting in your area.

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