N/A Completed N=73 Diagnostic

Kidney Response to Sepsis Affects Angiogenic Balance and Likelihood of CCI and PICS

Source: ClinicalTrials.gov NCT02276066 ↗

Enrolled (actual)

Serious AEs

53.4%

Results posted

Jul 2024

Primary outcomePrimary: 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

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.

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 Calculated GFR by Urea Concentration and Creatinine Clearance	—	—

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.

View full record on ClinicalTrials.gov →

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. Informational only — not medical advice.