Clinical Monitoring of Endothelial Dysfunction for Pregnant Women and in the Perioperative Course
24 de maio de 2018 atualizado por: 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.
Visão geral do estudo
Status
Rescindido
Condições
Tipo de estudo
Observacional
Inscrição (Real)
47
Contactos e Locais
Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.
Locais de estudo
-
-
-
Berlin, Alemanha, 13353
- Department of Anesthesiology and Intensive Care Medicine, Campus Virchow Klinikum, Charité - Universitaetsmedizin
-
-
Critérios de participação
Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.
Critérios de elegibilidade
Idades elegíveis para estudo
18 anos e mais velhos (Adulto, Adulto mais velho)
Aceita Voluntários Saudáveis
Sim
Gêneros Elegíveis para o Estudo
Fêmea
Método de amostragem
Amostra de Probabilidade
População do estudo
Female patients being treated in the Department of Gynecology and Obstetrics, Campus Virchow Klinikum, Charité - Universitaetsmedizin Berlin
Descrição
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)
Plano de estudo
Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.
Como o estudo é projetado?
Detalhes do projeto
Coortes e Intervenções
Grupo / Coorte |
|---|
|
Perioperative ovarian cancer patients
|
|
Pregnant patients
|
|
Female healthy volunteers
|
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Filtration coefficient
Prazo: 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
Prazo: 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
|
Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
All patients: Hemodynamic parameters
Prazo: 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)
Prazo: 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
Prazo: 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
Prazo: 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)
Prazo: during the operation
|
during the operation
|
|
|
Perioperative patients: Incidence and impact of organ dysfunctions
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: on the day of surgery
|
on the day of surgery
|
|
|
Perioperative patients: Duration until clinical discharge criteria were satisfied
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
|
Colaboradores e Investigadores
É aqui que você encontrará pessoas e organizações envolvidas com este estudo.
Patrocinador
Datas de registro do estudo
Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.
Datas Principais do Estudo
Início do estudo (Real)
29 de março de 2011
Conclusão Primária (Real)
29 de setembro de 2012
Conclusão do estudo (Real)
29 de setembro de 2012
Datas de inscrição no estudo
Enviado pela primeira vez
8 de março de 2011
Enviado pela primeira vez que atendeu aos critérios de CQ
8 de março de 2011
Primeira postagem (Estimativa)
9 de março de 2011
Atualizações de registro de estudo
Última Atualização Postada (Real)
25 de maio de 2018
Última atualização enviada que atendeu aos critérios de controle de qualidade
24 de maio de 2018
Última verificação
1 de maio de 2018
Mais Informações
Termos relacionados a este estudo
Outros números de identificação do estudo
- POPEYE
Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .
Ensaios clínicos em Disfunção Endotelial
-
Aarhus University HospitalRetiradoDistrofia Endotelial | Ceratopatia Bolhosa Secundária | Ceratoplastia Lamelar Posterior | Descemet's Stripping Endothelial KeratoplastyDinamarca