NCT02166580

Brief Summary

Noninvasive pulse pressure variation for the guidance of perioperative fluid therapy is compared with the gold standard of invasive measurements. Cardiac output is derived by the PICCO monitor. Hypothesis: Noninvasive CNAP PPV predicts fluid responsiveness. A grey zone for the prediction of fluid responsiveness will be defined.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
54

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jan 2014

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

First Submitted

Initial submission to the registry

December 4, 2012

Completed
1.1 years until next milestone

Study Start

First participant enrolled

January 1, 2014

Completed
6 months until next milestone

First Posted

Study publicly available on registry

June 18, 2014

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2015

Completed
Last Updated

June 6, 2017

Status Verified

June 1, 2017

Enrollment Period

1.5 years

First QC Date

December 4, 2012

Last Update Submit

June 3, 2017

Conditions

General Anaesthesia

Outcome Measures

Primary Outcomes (1)

  • Cardiac output

    Improvement of cardiac output dependent on PPV before volume challenge

    1, 2, 5, 10, 15 and 20 minutes after volume challange and

Eligibility Criteria

Age18 Years - 99 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients undergoing major surgery with the need for invasive arterial pressure monitoring

You may qualify if:

  • major surgery
  • need for invasive arterial measurements

You may not qualify if:

  • age under 18
  • cardiac dysrhythmia
  • vascular pathology at punction site

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital, Schleswig-Holstein. Departement of Anaesthesiology and Intensive Care Medicine

Kiel, 24106, Germany

Location

Related Publications (1)

  • Renner J, Gruenewald M, Hill M, Mangelsdorff L, Aselmann H, Ilies C, Steinfath M, Broch O. Non-invasive assessment of fluid responsiveness using CNAP technology is interchangeable with invasive arterial measurements during major open abdominal surgery. Br J Anaesth. 2017 Jan;118(1):58-67. doi: 10.1093/bja/aew399.

    PMID: 28039242DERIVED

Study Officials

  • Jochen Renner, PD Dr.

    University Hospital Schleswig-Holstein, Departement of Anaesthesia and Intensive Care Medicine

    PRINCIPAL INVESTIGATOR

  • Robert Hanss, Prof. Dr.

    University Hospital Schleswig-Holstein, Departement of Anaesthesia and Intensive Care Medicine

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PD Dr. med. Jochen Renner

Study Record Dates

First Submitted

December 4, 2012

First Posted

June 18, 2014

Study Start

January 1, 2014

Primary Completion

July 1, 2015

Study Completion

July 1, 2015

Last Updated

June 6, 2017

Record last verified: 2017-06

Locations

DE(1)