- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT00628264
Safety, Tolerability and Pharmacodynamics of AP214 Acetate in Patients Undergoing Cardiac Surgery
29. maj 2009 opdateret af: Action Pharma A/S
The purpose of the present research study is to investigate for the first time, the safety and tolerability of infusion doses of AP214 in subjects having heart surgery such as coronary bypass graft and/or valve repair or replacement surgery.
AP214, the investigational drug, is being developed to potentially prevent post-surgical kidney injury after thoracic aortic aneurysm repair.
Studieoversigt
Status
Afsluttet
Intervention / Behandling
Undersøgelsestype
Interventionel
Tilmelding (Forventet)
75
Fase
- Fase 2
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
-
-
Florida
-
Gainesville, Florida, Forenede Stater, 32601
- Shands Hospital at Alachua General Hospital
-
Gainesville, Florida, Forenede Stater, 32610
- Shands Hopsital at University of Florida
-
-
Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
18 år og ældre (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Alle
Beskrivelse
Inclusion Criteria:
- Has signed the trial specific informed consent form.
- Patients ≥ 18 years old, male or female, not of childbearing potential (postmenopausal or permanently sterilized e.g., tubal occlusion, hysterectomy, bilateral salpingectomy), regardless of ethnicity.
- Patients undergoing CABG, valve(s), CABG/valve and/or aortic root or ascending aortic aneurysm repair surgery.
- Cleveland Clinic Renal Score ≥ 2 (higher than average risk for AKI).
- EF ≥ 30%, evaluated within 2 months prior to screening visit.
Exclusion Criteria:
- Cardiac surgery to be performed "off pump" without cardiopulmonary bypass.
- Circulatory arrest in connection with aortic root or ascending aortic aneurysm repair surgery.
- Confirmed or suspected endocarditis.
- Requiring a reoperation on one of the valves within 3 months following the original valve surgical procedure.
- Receiving Aprotinin during the trial, from Screening to Day 90.
- Having undergone cardiovascular catheterization ≤ 48 hours prior to scheduled surgery.
- Active peptic ulcer disease and gastritis.
- Hemoccult positive stools, hematological, bleeding, and coagulation disorders.
- Receiving dopamine at renal doses (2-4 mcg/kg/min), from Screening to Day 90.
- S-Creatinine greater than 2.1 mg/dl.
- Known or suspected hypersensitivity to the investigational medicinal product.
- Known or suspected hypersensitivity to ondansetron or other selective 5-hydroxytryptamine 3 (5-HT3) receptor antagonists.
- Current participation in any other interventional clinical trial.
- Previously dosed with AP214.
- Use of investigational medicinal products within the previous 6 months.
- Body weight above 140 kg.
- History of any organ transplant.
- Women who are of childbearing potential, pregnant or breast-feeding.
- Current abuse of alcohol or substance, according to the investigator's medical judgment
- Has a mental incapacity or language barriers precluding adequate understanding of trial procedures.
- Is considered by the Investigator unsuitable to participate in the trial for any other reason for instance due to a significant serious underlying condition
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Forebyggelse
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Firedobbelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
---|---|
Placebo komparator: Placebo
|
Three placebo bolus infusions administered over 10 minutes (prior to skin incision, at time of clamp-release and 6 hours after clamp-release).
|
Eksperimentel: AP214
|
Three AP214 bolus infusions administered over 10 minutes (prior to skin incision, at time of clamp-release and 6 hours after clamp-release).
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Tidsramme |
---|---|
To assess the safety and tolerability of AP214 administered as three 10-minute bolus infusions, in patients undergoing cardiac surgery that are at increased risk of AKI (descriptive analysis of AEs and SAEs from Day 0-14).
Tidsramme: From day 0-14
|
From day 0-14
|
To assess the impact of AP214 on cardiac surgery induced systemic inflammatory response syndrome determined by the post-operative peak plasma concentrations of IL-6 and IL-10 from 0-24 hours
Tidsramme: 0-24 hours
|
0-24 hours
|
Sekundære resultatmål
Resultatmål |
Tidsramme |
---|---|
To assess the safety and tolerability of AP214 at an organ level as well as in terms of the overall mortality (heart, CNS, lung, wound, mortality)
Tidsramme: Day 0-90
|
Day 0-90
|
To assess the impact of AP214 on cardiac surgery induced systemic inflammatory response syndrome (post-operative peak plasma concentrations of TNF-α and IL-8 and AUC for TNF-α, IL-6, IL-8 and IL-10).
Tidsramme: 0-24 hours
|
0-24 hours
|
To assess the impact of AP214 for renal protection as measured by the development of post-surgical acute kidney injury (AKIN score)
Tidsramme: Day 0-14
|
Day 0-14
|
To assess the impact of AP214 on the development of post-surgical left ventricular dysfunction (determined by changes in left ventricular function from pre to post coronary bypass by transesophageal echocardiography
Tidsramme: 0-24 hours
|
0-24 hours
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Efterforskere
- Ledende efterforsker: Thomas M Beaver, MD, MPH, Division of Thoracic and Cardiovascular Surgery , University of Florida College of Medicine
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart
1. marts 2008
Primær færdiggørelse (Forventet)
1. juni 2009
Studieafslutning (Forventet)
1. juni 2009
Datoer for studieregistrering
Først indsendt
25. februar 2008
Først indsendt, der opfyldte QC-kriterier
25. februar 2008
Først opslået (Skøn)
5. marts 2008
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
1. juni 2009
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
29. maj 2009
Sidst verificeret
1. maj 2009
Mere information
Begreber relateret til denne undersøgelse
Andre undersøgelses-id-numre
- AP214-CS004
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .
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