- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT01311297
Clinical Monitoring of Endothelial Dysfunction for Pregnant Women and in the Perioperative Course
24 maj 2018 uppdaterad av: Claudia Spies
Clinical Monitoring of Endothelial Dysfunction for Pregnant Women and in the Perioperative Course - a Pilot Study
A single- center prospective observational study.
This study evaluates different aspects of endothelial function.
It investigates the endothelial leakage with the venous occlusion plethysmography and the flow-mediated vasodilatation by ischaemia reperfusion testing.
Studieöversikt
Status
Avslutad
Betingelser
Studietyp
Observationell
Inskrivning (Faktisk)
47
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studieorter
-
-
-
Berlin, Tyskland, 13353
- Department of Anesthesiology and Intensive Care Medicine, Campus Virchow Klinikum, Charité - Universitaetsmedizin
-
-
Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
18 år och äldre (Vuxen, Äldre vuxen)
Tar emot friska volontärer
Ja
Kön som är behöriga för studier
Kvinna
Testmetod
Sannolikhetsprov
Studera befolkning
Female patients being treated in the Department of Gynecology and Obstetrics, Campus Virchow Klinikum, Charité - Universitaetsmedizin Berlin
Beskrivning
Inclusion Criteria:
- Offered patient information and written informed consent
Female patients aged greater than or equal to 18 years:
- for reduction of a primary ovarian tumour or recidive of an ovarian tumour
pregnant patients with:
- clinical normal pregnancy
- pregnancy with weight gain of more than 10 kg
- pregnancy and gestosis
- healthy volunteers
Exclusion Criteria:
- Persons without the capacity to consent
- Unability of German language use
- Lacking willingness to save and hand out data within the study
- Accommodation in an institution due to an official or judicial order
- (Unclear) history of alcohol or substances disabuse
- Coworker of the Charité
- Advanced disease of the oesophagus or upper respiratory tract
- Operation in the area of the oesophagus or nasopharynx within the last two months
- Neurological or psychiatric disease
- CHF (congestive heart failure) according to (New York Heart Association) classification - NYHA class IV at the beginning of hospital stay
- American Society of Anaesthesiologists (ASA) classification greater than IV
- Renal insufficiency (dependency of haemodialysis)
- Pulmonal oedema in thorax x-ray
- History of intracranial hemorrhage within one year of participation in the study
- Conditions following venous thrombosis within the last three years before study inclusion
- Inflammatory or reflective disease of blood vessels (Raynaud-Syndrome, Vasculitis)
- Inherent connective tissue disease(e.g. Marfan Syndrome)
Studieplan
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
Kohorter och interventioner
Grupp / Kohort |
---|
Perioperative ovarian cancer patients
|
Pregnant patients
|
Female healthy volunteers
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
---|---|---|
Filtration coefficient
Tidsram: perioperatively up to the fifth postoperative day in patients undergoing surgery
|
Endothelial parameter from the examination with venous occlusion plethysmography.
|
perioperatively up to the fifth postoperative day in patients undergoing surgery
|
Filtration coefficient
Tidsram: up to one hour single measurement in pregnant woman
|
Endothelial parameter from the examination with venous occlusion plethysmography.
|
up to one hour single measurement in pregnant woman
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
---|---|---|
All patients: Hemodynamic parameters
Tidsram: perioperatively up to the fifth postoperative day in patients undergoing surgery
|
perioperatively up to the fifth postoperative day in patients undergoing surgery
|
|
All patients: Markers of endothelial dysfunction (ICAM-1, E-Selectin, vWF)
Tidsram: perioperatively up to the fifth postoperative day in patients undergoing surgery
|
perioperatively up to the fifth postoperative day in patients undergoing surgery
|
|
All patients: Endothelial flow-mediated vasodilatation
Tidsram: perioperatively up to the fifth postoperative day in patients undergoing surgery
|
perioperatively up to the fifth postoperative day in patients undergoing surgery
|
|
Perioperative patients: Blood loss
Tidsram: perioperatively up to the fifth postoperative day in patients undergoing surgery
|
perioperatively up to the fifth postoperative day in patients undergoing surgery
|
|
Perioperative patients: Parameter of monitored sedation (BIS - Monitoring)
Tidsram: during the operation
|
during the operation
|
|
Perioperative patients: Incidence and impact of organ dysfunctions
Tidsram: perioperatively up to the fifth postoperative day in patients undergoing surgery
|
perioperatively up to the fifth postoperative day in patients undergoing surgery
|
|
Perioperative patients: Pain
Tidsram: perioperatively up to the fifth postoperative day in patients undergoing surgery
|
Patient self-assessed postoperative pain levels during rest using an unmarked zero to one hundred mm visual analog scale (VAS)
|
perioperatively up to the fifth postoperative day in patients undergoing surgery
|
Perioperative patients: Body weight
Tidsram: perioperatively up to the fifth postoperative day in patients undergoing surgery
|
perioperatively up to the fifth postoperative day in patients undergoing surgery
|
|
Perioperative patients: Satisfaction of the patients, surgeon and anesthesiologist
Tidsram: on the day of surgery
|
on the day of surgery
|
|
Perioperative patients: Duration until clinical discharge criteria were satisfied
Tidsram: perioperatively up to the fifth postoperative day in patients undergoing surgery
|
Postanesthesia Discharge Scoring System (PADS) for Determining Home-Readiness
|
perioperatively up to the fifth postoperative day in patients undergoing surgery
|
Perioperative patients: Intensive care unit average length of stay; hospital average length of stay
Tidsram: perioperatively up to the fifth postoperative day in patients undergoing surgery
|
perioperatively up to the fifth postoperative day in patients undergoing surgery
|
|
Perioperative patients: Quality of life
Tidsram: perioperatively up to hospital discharge in patients undergoing surgery, an expexcted average of two weeks
|
Descriptive system of health-related quality of life states consisting of five dimensions (mobility, self-care, usual activities, pain/discomfort, anxiety/depression) each of which can take one of three responses.
The responses record three levels of severity (no problems/some or moderate problems/extreme problems) within a particular EQ-5D dimension.
|
perioperatively up to hospital discharge in patients undergoing surgery, an expexcted average of two weeks
|
Pregnant patients: History data of the pregnancy, parameter of Gestosis
Tidsram: up to one hour single measurement in pregnant woman
|
Gestosis: toxemia of pregnancy
|
up to one hour single measurement in pregnant woman
|
All patients: Immunological Markers
Tidsram: perioperatively up to the fifth postoperative day in patients undergoing surgery
|
Differences in selected immunologic parameters among others IL-6, IL-10
|
perioperatively up to the fifth postoperative day in patients undergoing surgery
|
Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Sponsor
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart (Faktisk)
29 mars 2011
Primärt slutförande (Faktisk)
29 september 2012
Avslutad studie (Faktisk)
29 september 2012
Studieregistreringsdatum
Först inskickad
8 mars 2011
Först inskickad som uppfyllde QC-kriterierna
8 mars 2011
Första postat (Uppskatta)
9 mars 2011
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
25 maj 2018
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
24 maj 2018
Senast verifierad
1 maj 2018
Mer information
Termer relaterade till denna studie
Andra studie-ID-nummer
- POPEYE
Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .
Kliniska prövningar på Endotel dysfunktion
-
Centre Hospitalier Régional Metz-ThionvilleAvslutadDescemets Stripping Automated Endothelial Keratoplasty
-
Oslo University HospitalRekryteringDescemet Stripping Automated Endothelial Keratoplasty (DSAEK) | Descemet Membrane Endothelial Keratoplasty (DMEK)Norge
-
Stealth BioTherapeutics Inc.AvslutadFuchs' corneal endothelial dystrophy (FCED)Förenta staterna
-
Oslo University HospitalOkändKornealdystrofier, ärftlig | Fuchs endoteldystrofi | Korneatransplantation | Descemet Stripping Automated Endothelial KeratoplastyNorge
-
Singapore National Eye CentreNational University, SingaporeAvslutad
-
University of WaterlooAvslutadMeibomian Gland Dysfunction (MGD)Kanada
-
Grand Valley State UniversityAnmälan via inbjudanMetabolic Associated-dysfunction Steatotic Lever Disease (MASLD) | Metabolic Associated-dysfunction Steatohepatit (MASH)Förenta staterna
-
Azura OphthalmicsThe University of New South WalesAvslutadMeibomian Gland Dysfunction (MGD) | Kontaktlinsobehag (CLD)Australien
-
Johnson & Johnson Surgical Vision, Inc.AvslutadGrå starr | Meibomian Gland Dysfunction (MGD)Förenta staterna
-
Centre Hospitalier Régional Metz-ThionvilleAvslutadPseudofakisk bullös keratopati | Fuchs endotelial hornhinnedystrofi | Descemet Membrane Endothelial Keratoplasty | TransplantatavskiljningFrankrike