Severe Sepsis in Children - IMPRESS-C (NCT02598674) | Clinical Trial Compass
WithdrawnNot Applicable
Severe Sepsis in Children - IMPRESS-C
Stopped: Expired IRB
United States0Started 2019-10
Plain-language summary
Sepsis is the most common cause of childhood death worldwide. Millions of children survive, but are left with impaired health. Sepsis-related Acute Kidney Injury (sAKI) is increasingly recognized as a significant factor associated with long-term mortality among different patient populations. Renal dysfunction and subsequent chronic kidney disease is implicated in the development of hypertension and cardiovascular disease. The investigators overall hypothesis is that, in the pediatric population, sepsis-related AKI will have unrecognized, long-term consequences with regard to kidney function, endothelial function, blood pressure control, and overall health.
Who can participate
Age range
7 Years – 17 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:
For all patients:
* Ability to assent (age 7-17 at time of participation in the study)
* If taking antihypertensive medication, prescribing practitioner's written approval to participate
For sAKI patients:
* Hospitalization with a diagnosis of sepsis from 1998-2014
* Severe AKI as defined by the pEDRIFLE criteria during incident sepsis admission
* Participation in cognitive survey study with completion of the PedsQL survey
For healthy control patients:
• Patients from the neurology service undergoing MRI with gadolinium as a part of their clinical care
Exclusion Criteria:
For all patients:
* Known pre-existing CKD as defined by history of kidney transplant or long-term dialysis
* Age greater than 17 years at the time of incident sepsis admission
* AKI from primary kidney disease including acute glomerulonephritis and obstructive uropathy
* Pregnancy at the time of enrollment
* Known or suspected allergy to gadolinium based contrast
* Known or suspected allergy to iodohippurate will be excluded from RPF measurement with iodohippurate
* Heart failure or condition whereby the administration of 0.9% normal saline would be contraindicated
* If taking antihypertensive medication, lack of prescribing practitioner's written approval to participate
For healthy control patients:
* Chronic kidney disease
* History of acute kidney injury or GFR \<100 History of chronic illnesses deemed to predispose to renal or cardiovascular dysfunction or abnormalities Su…
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.