N/A
N=73
Kidney Response to Sepsis Affects Angiogenic Balance and Likelihood of CCI and PICS
Sepsis
Bottom Line
View on ClinicalTrials.gov: NCT02276066 ↗Enrolled (actual)
73
Serious AEs
53.4%
Results posted
Jul 2024
Primary outcome: Primary: Delta Curve Between Calculated GFR and GFR Measured by Iohexol at Baseline — 91.5; 88.3; 93.6; 90.0 ml/min/1.73m2 — p=<0.05
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- GFR by Iohexol (Diagnostic_test); Urine Collection (Diagnostic_test); Blood samples (Diagnostic_test)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of Florida
- Primary completion
- May 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Delta Curve Between Calculated GFR and GFR Measured by Iohexol at Baseline |
91.5; 88.3; 93.6; 90.0 | <0.05 sig |
| PRIMARY Delta Curve Between Calculated GFR and GFR Measured by Iohexol at 1 Year Follow-up. |
71.4; 58.8 | — |
| SECONDARY Estimated GFR by Serum Creatinine |
83.0; 83.2 | — |
| SECONDARY Estimated GFR by Serum Creatinine |
83.0; 83.2 | — |
| SECONDARY Calculated GFR by Urea Concentration and Creatinine Clearance |
— | — |
| SECONDARY Calculated GFR by Urea Concentration and Creatinine Clearance |
— | — |
Summary
This study investigates the mechanism by which kidney dysfunction perpetuates inflammation, immunosuppression, and catabolism (PICS) in chronic critical illness. The investigators will test the hypothesis that persistent kidney dysfunction in sepsis associated by chronic critical illness contributes to decreased survival through the development of PICS. In chronic critical illness, the persistence of the inflammatory state may lead to capillary rarefication in the kidney causing accelerated chronic kidney disease. Progression of chronic kidney disease during chronic critical illness can drive PICS. Indeed, many of the features of chronic critical illness are consistent with the protein-energy malnutrition and muscle wasting associated with chronic kidney disease. Thus, the kidney can play a contributory role in chronic critical illness and PICS.
Eligibility Criteria
Inclusion Criteria
- Presence in the surgery or trauma ICU
- Age of ≥18 years
- Entrance into our sepsis protocol
- Ability to obtain informed consent.
Exclusion Criteria
- Expected lifespan of the patient is less than 3 months due to severe pre-existing comorbidities (ex. recurrent, advanced or metastatic cancer)
- Severe traumatic brain injury (evidence of neurologic injury on CT scan and a GCS <8)
- Refractory shock (i.e., patients who die within 12 hours)
- Uncontrollable source of sepsis (e.g., irreversible disease state such as unresectable dead bowel)
- Patient or patient's family are not committed to aggressive management of the patient's condition and/or the patient has a DNR/DNI on file.
- Severe CHF (NY Heart Association Class IV)
- Child-Pugh C liver disease or pre-liver transplant.
- Known HIV infection with CD4 count <200 cells/mm3
- Organ transplant recipient on immunosuppressive agents
- Known pregnancy and mother's that are breastfeeding
- Prisoners
- Institutionalized patients
- Inability to obtain informed consent.
- Chemotherapy or radiotherapy within 30 days prior to sepsis.
- End stage renal disease on admission.
Data sourced from ClinicalTrials.gov (NCT02276066). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.