NCT01819337

Brief Summary

The aim of this study is to identify if there exists a correlation between the preoperative cardiopulmonary capacity - measured in MET's - and the perioperative lactate serum level.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
1,502

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 2013

Shorter than P25 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

First Submitted

Initial submission to the registry

February 8, 2013

Completed
21 days until next milestone

Study Start

First participant enrolled

March 1, 2013

Completed
26 days until next milestone

First Posted

Study publicly available on registry

March 27, 2013

Completed
5 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2013

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2013

Completed
Last Updated

September 17, 2013

Status Verified

September 1, 2013

Enrollment Period

1 month

First QC Date

February 8, 2013

Last Update Submit

September 15, 2013

Conditions

Sensitivity Training GroupsComplication, Cardio-respiratory

Outcome Measures

Primary Outcomes (1)

  • lactate - venous blood gas analysis

    mmol/l

    venous lactate will be measured at anaesthesia induction and anesthesia termination - the average time frame is 2 hours

Secondary Outcomes (3)

  • icu in hospital mortality

    icu patients will be followed over their hospital stay over a maximum period of 6 months

  • hemoglobin - venous blood gas analysis

    hemoglobin will be measured at anaesthesia induction and anesthesia termination - the average time frame is 2 hours

  • icu ventilation time

    icu patients will be followed over their hospital stay over a maximum period of 6 months

Eligibility Criteria

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

All patients undergoing elective/urgent or emergency surgery

You may qualify if:

  • Age \> 18 years

You may not qualify if:

  • Cardiac surgery

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Helios Klinikum Wuppertal

Wuppertal, North Rhine-Westphalia, 42283, Germany

Location

Study Officials

  • Gerhard Schneider, Prof.

    Dept. Anaesthesiology

    STUDY CHAIR

Study Design

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

Study Record Dates

First Submitted

February 8, 2013

First Posted

March 27, 2013

Study Start

March 1, 2013

Primary Completion

April 1, 2013

Study Completion

August 1, 2013

Last Updated

September 17, 2013

Record last verified: 2013-09

Locations

DE(1)