NCT01455766

Brief Summary

The hypothesis of this observational single-center clinical study was to explore the volumetric hemodynamic monitoring in the perioperative period in major and risky thoracic intervention. The investigators monitored the changes in the volumes of blood in the central vessels and heart chambers as well as a volume of fluid in pulmonary tissue (i. e. extravascular lung water).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jun 2005

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2005

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2008

Completed
3.7 years until next milestone

First Submitted

Initial submission to the registry

October 17, 2011

Completed
3 days until next milestone

First Posted

Study publicly available on registry

October 20, 2011

Completed
12 days until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2011

Completed
Last Updated

September 5, 2012

Status Verified

September 1, 2012

Enrollment Period

2.7 years

First QC Date

October 17, 2011

Last Update Submit

September 4, 2012

Conditions

PneumonectomyAcute Pulmonary Edema

Keywords

postpneumonectomy pulmonary edemaextravascular lung water

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

The study population includes the patients scheduled for extended thoracic resections (lobar resection and pneumonectomy) due to bronchial cancer or severe destructive pulmonary infection (abscess and/or pneumonia).

You may qualify if:

  • Informed consent
  • Age above 18 and below 80
  • Confirmed malignant bronchial neoplasm or
  • Destructive pulmonary infection

You may not qualify if:

  • Pregnant
  • Severe pulmonary hypertension
  • Pulmonary tuberculosis
  • Severe occlusive atherosclerosis of lower extremities

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Regional Hospital of Arkhangelsk

Arkhangelsk, Arkhangelskaya oblast, 163000, Russia

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Blood plasma for non-specified additional retrospective tests.

Study Officials

  • Vsevolod V. Kuzkov, MD, PhD

    Northern State Medical University

    PRINCIPAL INVESTIGATOR

  • Mikhail M. Orlov, MD

    Regional hospital of Arkhangelsk

    PRINCIPAL INVESTIGATOR

  • Mikhail Y. Kirov, MD, PhD

    Northern State Medical University

    STUDY CHAIR

  • Lars J. Bjertnaes, MD, PhD

    University of Trmsoe, Tromsoe, Norway

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor, MD, PhD

Study Record Dates

First Submitted

October 17, 2011

First Posted

October 20, 2011

Study Start

June 1, 2005

Primary Completion

February 1, 2008

Study Completion

November 1, 2011

Last Updated

September 5, 2012

Record last verified: 2012-09

Locations

RU(1)