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NCT02598674: IMPRESS-C
Long Term Impact of Pediatric Acute Renal Injury in Severe Sepsis in in Children - IMPRESS-C
trial testing Iodohippurate in Acute Kidney Injury. Withdrawn.
1 September 2021
Quick facts
| Lead sponsor | University of Florida |
|---|---|
| Status | Withdrawn |
| Study type | OBSERVATIONAL |
| Start date | 1 October 2019 |
| Primary completion | 1 September 2021 |
| Estimated completion | 1 September 2021 |
| Sites | 1 location across United States |
Drugs / interventions tested
- Iodohippurate — full drug profile →
- 24 hour ambulatory Blood Pressure
- Peripheral Arterial Tonometry
- Pulse Wave Velocity
- Gadolinium (GADOLINIUM) — full drug profile →
Conditions studied
- Acute Kidney Injury — all drugs for Acute Kidney Injury →
- Chronic Kidney Disease — all drugs for Chronic Kidney Disease →
- Hypertension — all drugs for Hypertension →
Sponsor
University of Florida
Who can join
Adults 7 to 17, any sex, with Acute Kidney Injury or Chronic Kidney Disease. Healthy volunteers can join.
What's being measured
Primary outcomes are the specific endpoints the trial is designed to prove or disprove.
-
Glomerular Function Rate (GFR) filtration
Time frame: Day 2
Magnevist Gadolinium (GD)-diethylene-triamine-pentaacetic acid-bis-oleate (0.07 to 0.14 mL/kg) will be used to determine GFR. -
Renal plasma flow (RPF) filtration
Time frame: Day 2
An injection of non-radioactive iodohippurate (0.07 mL/kg) will be administered to determine renal plasma flow (RPF) filtration. -
Proteinuria will be measured in the urine
Time frame: Day 2
Proteinuria may be a sign of renal (kidney) damage. Since serum proteins are readily reabsorbed from urine, the presence of excess protein indicates either an insufficiency of absorption or impaired filtration. People with diabetes may have damaged nephrons and develop proteinuria. -
Cystatin C will be measured in the blood
Time frame: Day 2
Cystatin C can be measured in a random sample of serum (the fluid in blood from which the red blood cells and clotting factors have been removed) using immunoassays such as nephelometry or particle-enhanced turbidimetry.
Sponsor's own description
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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT02598674
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for Acute Kidney Injury
Currently open trials in the same condition.
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- NCT07215702 — A Study to Investigate the Efficacy, Safety, and Tolerability of AZD4144in Participants With Sepsis-associated Acute Kid · Phase 2 · recruiting
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Other University of Florida trials
Trials by the same sponsor.
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT02598674 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by University of Florida
- Last refreshed: 7 December 2020
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT02598674.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing