Clinical Monitoring of Endothelial Dysfunction for Pregnant Women and in the Perioperative Course
24. mai 2018 oppdatert 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.
Studieoversikt
Status
Avsluttet
Forhold
Studietype
Observasjonsmessig
Registrering (Faktiske)
47
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
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Berlin, Tyskland, 13353
- Department of Anesthesiology and Intensive Care Medicine, Campus Virchow Klinikum, Charité - Universitaetsmedizin
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Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
18 år og eldre (Voksen, Eldre voksen)
Tar imot friske frivillige
Ja
Kjønn som er kvalifisert for studier
Hunn
Prøvetakingsmetode
Sannsynlighetsprøve
Studiepopulasjon
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:
- 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
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
Kohorter og intervensjoner
Gruppe / Kohort |
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Perioperative ovarian cancer patients
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Pregnant patients
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Female healthy volunteers
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Filtration coefficient
Tidsramme: perioperatively up to the fifth postoperative day in patients undergoing surgery
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Endothelial parameter from the examination with venous occlusion plethysmography.
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perioperatively up to the fifth postoperative day in patients undergoing surgery
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Filtration coefficient
Tidsramme: up to one hour single measurement in pregnant woman
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Endothelial parameter from the examination with venous occlusion plethysmography.
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up to one hour single measurement in pregnant woman
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Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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All patients: Hemodynamic parameters
Tidsramme: perioperatively up to the fifth postoperative day in patients undergoing surgery
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perioperatively up to the fifth postoperative day in patients undergoing surgery
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All patients: Markers of endothelial dysfunction (ICAM-1, E-Selectin, vWF)
Tidsramme: perioperatively up to the fifth postoperative day in patients undergoing surgery
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perioperatively up to the fifth postoperative day in patients undergoing surgery
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All patients: Endothelial flow-mediated vasodilatation
Tidsramme: perioperatively up to the fifth postoperative day in patients undergoing surgery
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perioperatively up to the fifth postoperative day in patients undergoing surgery
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Perioperative patients: Blood loss
Tidsramme: perioperatively up to the fifth postoperative day in patients undergoing surgery
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perioperatively up to the fifth postoperative day in patients undergoing surgery
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Perioperative patients: Parameter of monitored sedation (BIS - Monitoring)
Tidsramme: during the operation
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during the operation
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Perioperative patients: Incidence and impact of organ dysfunctions
Tidsramme: perioperatively up to the fifth postoperative day in patients undergoing surgery
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perioperatively up to the fifth postoperative day in patients undergoing surgery
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Perioperative patients: Pain
Tidsramme: perioperatively up to the fifth postoperative day in patients undergoing surgery
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Patient self-assessed postoperative pain levels during rest using an unmarked zero to one hundred mm visual analog scale (VAS)
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perioperatively up to the fifth postoperative day in patients undergoing surgery
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Perioperative patients: Body weight
Tidsramme: perioperatively up to the fifth postoperative day in patients undergoing surgery
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perioperatively up to the fifth postoperative day in patients undergoing surgery
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Perioperative patients: Satisfaction of the patients, surgeon and anesthesiologist
Tidsramme: on the day of surgery
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on the day of surgery
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Perioperative patients: Duration until clinical discharge criteria were satisfied
Tidsramme: perioperatively up to the fifth postoperative day in patients undergoing surgery
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Postanesthesia Discharge Scoring System (PADS) for Determining Home-Readiness
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perioperatively up to the fifth postoperative day in patients undergoing surgery
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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
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perioperatively up to the fifth postoperative day in patients undergoing surgery
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Perioperative patients: Quality of life
Tidsramme: perioperatively up to hospital discharge in patients undergoing surgery, an expexcted average of two weeks
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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.
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perioperatively up to hospital discharge in patients undergoing surgery, an expexcted average of two weeks
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Pregnant patients: History data of the pregnancy, parameter of Gestosis
Tidsramme: up to one hour single measurement in pregnant woman
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Gestosis: toxemia of pregnancy
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up to one hour single measurement in pregnant woman
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All patients: Immunological Markers
Tidsramme: perioperatively up to the fifth postoperative day in patients undergoing surgery
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Differences in selected immunologic parameters among others IL-6, IL-10
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perioperatively up to the fifth postoperative day in patients undergoing surgery
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Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart (Faktiske)
29. mars 2011
Primær fullføring (Faktiske)
29. september 2012
Studiet fullført (Faktiske)
29. september 2012
Datoer for studieregistrering
Først innsendt
8. mars 2011
Først innsendt som oppfylte QC-kriteriene
8. mars 2011
Først lagt ut (Anslag)
9. mars 2011
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
25. mai 2018
Siste oppdatering sendt inn som oppfylte QC-kriteriene
24. mai 2018
Sist bekreftet
1. mai 2018
Mer informasjon
Begreper knyttet til denne studien
Andre studie-ID-numre
- POPEYE
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