Kidney Response to Sepsis Affects Angiogenic Balance and Likelihood of CCI and PICS (NCT02276066) | Clinical Trial Compass
CompletedNot Applicable
Kidney Response to Sepsis Affects Angiogenic Balance and Likelihood of CCI and PICS
United States73 participantsStarted 2015-02
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Delta Curve Between Calculated GFR and GFR Measured by Iohexol at Baseline
Timeframe: For Arm 1 baseline is measured GFR at 14 days inhospital with sepsis or sepsis diagnosis. For Arm 2 baseline is measured GFR at discharge date prior to day 14 of hospitalizaton with sepsis or sepsis diagnosis.
2
Delta Curve Between Calculated GFR and GFR Measured by Iohexol at 1 Year Follow-up.