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

NCT01311297 | Terminated

• 1 other identifier: POPEYE
• Study Type: observational
• Target: 47
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Endothelial Dysfunction

Outcome Measures

Primary Outcomes (2)

• Filtration coefficient

  Endothelial parameter from the examination with venous occlusion plethysmography.

  perioperatively up to the fifth postoperative day in patients undergoing surgery

• Filtration coefficient

  Endothelial parameter from the examination with venous occlusion plethysmography.

  up to one hour single measurement in pregnant woman

Secondary Outcomes (14)

• All patients: Hemodynamic parameters

  perioperatively up to the fifth postoperative day in patients undergoing surgery

• All patients: Markers of endothelial dysfunction (ICAM-1, E-Selectin, vWF)

  perioperatively up to the fifth postoperative day in patients undergoing surgery

• All patients: Endothelial flow-mediated vasodilatation

  perioperatively up to the fifth postoperative day in patients undergoing surgery

• Perioperative patients: Blood loss

  perioperatively up to the fifth postoperative day in patients undergoing surgery

• Perioperative patients: Parameter of monitored sedation (BIS - Monitoring)

  during the operation

Study Arms (3)

Perioperative ovarian cancer patients

Pregnant patients

Female healthy volunteers

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

• 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

You may not qualify if:

• 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
• Inflammatory or reflective disease of blood vessels (Raynaud-Syndrome, Vasculitis)

Sponsors & Collaborators

• Claudia Spies: lead

Study Sites (1)

Department of Anesthesiology and Intensive Care Medicine, Campus Virchow Klinikum, Charité - Universitaetsmedizin

Berlin, 13353, Germany

Location

Related Publications (1)

• Feldheiser A, Dathe JJ, Heinig S, Peitzner K, Kaufner L, Hunsicker O, von Haefen C, Sehouli J, Spies C. Perioperative micro-arterial function and extravasation in cytoreductive ovarian cancer surgery: an observational study. Intensive Care Med Exp. 2026 Jan 25;14(1):7. doi: 10.1186/s40635-025-00839-4.

  PMID: 41580514 DERIVED

Biospecimen

Retention: SAMPLES WITHOUT DNA

Whole blood, serum

Study Officials

• Claudia Spies, MD Prof.

  Charite University, Berlin, Germany

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Prof. , MD Director of the Department of Anaesthesiology and Intensive Care Medicine CVK/CCM

Study Record Dates

• First Submitted: March 8, 2011
• First Posted: March 9, 2011
• Study Start: March 29, 2011
• Primary Completion: September 29, 2012
• Study Completion: September 29, 2012
• Last Updated: May 25, 2018

Record last verified: 2018-05

Locations

DE (1)