Denne side blev automatisk oversat, og nøjagtigheden af ​​oversættelsen er ikke garanteret. Der henvises til engelsk version for en kildetekst.

Clinical Monitoring of Endothelial Dysfunction for Pregnant Women and in the Perioperative Course

24. maj 2018 opdateret af: 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.

Studieoversigt

Status

Afsluttet

Betingelser

Undersøgelsestype

Observationel

Tilmelding (Faktiske)

47

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Tyskland
      • Berlin, Tyskland, 13353
        • Department of Anesthesiology and Intensive Care Medicine, Campus Virchow Klinikum, Charité - Universitaetsmedizin

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

Ja

Køn, der er berettiget til at studere

Kvinde

Prøveudtagningsmetode

Sandsynlighedsprøve

Studiebefolkning

Female patients being treated in the Department of Gynecology and Obstetrics, Campus Virchow Klinikum, Charité - Universitaetsmedizin Berlin

Beskrivelse

Inclusion Criteria:

  • Offered patient information and written informed consent

  • Female patients aged greater than or equal to 18 years:

    1. for reduction of a primary ovarian tumour or recidive of an ovarian tumour

    2. pregnant patients with:

      • clinical normal pregnancy
      • pregnancy with weight gain of more than 10 kg
      • pregnancy and gestosis
    3. 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

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

Kohorter og interventioner

Gruppe / kohorte
Perioperative ovarian cancer patients
Pregnant patients
Female healthy volunteers

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Filtration coefficient
Tidsramme: 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
Tidsramme: 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

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
All patients: Hemodynamic parameters
Tidsramme: 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)
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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)
Tidsramme: during the operation
during the operation
Perioperative patients: Incidence and impact of organ dysfunctions
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: on the day of surgery
on the day of surgery
Perioperative patients: Duration until clinical discharge criteria were satisfied
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Claudia Spies

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 (Faktiske)

29. marts 2011

Primær færdiggørelse (Faktiske)

29. september 2012

Studieafslutning (Faktiske)

29. september 2012

Datoer for studieregistrering

Først indsendt

8. marts 2011

Først indsendt, der opfyldte QC-kriterier

8. marts 2011

Først opslået (Skøn)

9. marts 2011

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

25. maj 2018

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

24. maj 2018

Sidst verificeret

1. maj 2018

Mere information

Begreber relateret til denne undersøgelse

Andre undersøgelses-id-numre

  • POPEYE

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 .

Kliniske forsøg med Endotel dysfunktion

Søg i lignende forsøg

Sponsorer og samarbejdspartnere

Medicinske tilstande

Narkotikainterventioner

CROs by country

CROs in Mauritius

Betingelser

Sjældne sygdomme

Narkotikainterventioner

Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

Abonner