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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:

    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

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

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