RecruitingNot Applicable

Physiologic Signals and Signatures With the Accuryn Monitoring System - The Accuryn Registry

United States2,500 participantsStarted 2020-12-21

Plain-language summary

The Accuryn Registry Study is an open-ended, global, multi-center, retrospective and prospective, single-arm data collection study with an FDA cleared device. The target population are cardiovascular surgery patients. Physiologic data measurements will be collected from enrolled subjects using electronic medical records and data streams via the Accuryn Monitoring System.

Who can participate

Age range18 Years

SexALL

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Inclusion criteria

✓. Signed or Verbal Informed Consent as required by IRB (if applicable).
✓. Adult (age ≥ 18).
✓. Monitored on the Accuryn® Monitoring System during their procedure and ICU stay (for retrospective enrollment).
✓. Patient is undergoing cardiac surgical intervention(s).

Exclusion criteria

✕. Known history of advanced chronic kidney disease defined by an estimated glomerular filtration rate (eGFR) \<20 mL/min/1.73m2 within 30 days prior to procedure.
✕. The patient is unsuitable for the study, in the opinion of the investigator. This may include vulnerable patient populations such as pregnant women, prisoners ,or those detained in a penal institution.

What they're measuring

Urine Output (UO)

Timeframe: 30 days

Intra-Abdominal Pressure (IAP)

Timeframe: 30 days

Temperature (T)

Timeframe: 30 days

Intraabdominal Hypertension (IAH)

Timeframe: 30 days

Abdominal Compartment Syndrome (ACS)

Timeframe: 30 days

Acute Kidney Injury (AKI)

Timeframe: 30 days

Trial details

NCT IDNCT04669548

SponsorPotrero Medical

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2026-12-31

Contact for this trial

Bev Ann Blackwell

256-679-5422 bblackwell@potreromed.com

View on ClinicalTrials.gov More Intraabdominal Hypertension trials