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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01819337
Other study ID # Lactate1
Secondary ID
Status Completed
Phase N/A
First received February 8, 2013
Last updated September 15, 2013
Start date March 2013
Est. completion date August 2013

Study information

Verified date September 2013
Source University of Witten/Herdecke
Contact n/a
Is FDA regulated No
Health authority Germany: Ethics Commission
Study type Observational

Clinical Trial 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.


Description:

The determination of the cardiopulmonary (c/p) capacity is very important for the evaluation of every patient undergoing surgery. The ability to climb at least two flight of stairs is seen to be an acceptable c/p capacity for surgery. There are several ways to evaluate the fitness of patients. A common method to estimate the cardiopulmonary capacity is defining patients through the MET's (metabolic equivalents) scale. MET's can be defined relatively easy through a simple questionnaire. Patients with a reduced c/p capacity have less than 4 MET's, patients with a relatively good c/p capacity have 4-10 MET's and patients with a excellent c/p capacity have more than 10 MET's.

The lactate level in blood serum is a common parameter to asses anaerobic metabolism in patients. A high lactate level correlates with higher mortality rates and outcome.

To yet it is not clear if there exists a correlation between the preoperative cardiopulmonary capacity measured in MET's and the perioperative lactate level. We hypothysed that patients with a reduced cardiopulmonary capacity are associated with higher perioperative lactate levels, as these group of patients compensate the stressors operation/anesthesia less than patients with a good c/p capacity.


Recruitment information / eligibility

Status Completed
Enrollment 1502
Est. completion date August 2013
Est. primary completion date April 2013
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Age > 18 years

Exclusion Criteria:

- Cardiac surgery

Study Design

Observational Model: Cohort, Time Perspective: Prospective


Locations

Country Name City State
Germany Helios Klinikum Wuppertal Wuppertal NRW

Sponsors (1)

Lead Sponsor Collaborator
University of Witten/Herdecke

Country where clinical trial is conducted

Germany, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 No
Secondary icu in hospital mortality icu patients will be followed over their hospital stay over a maximum period of 6 months No
Secondary hemoglobin - venous blood gas analysis g/dl hemoglobin will be measured at anaesthesia induction and anesthesia termination - the average time frame is 2 hours No
Secondary icu ventilation time hours/days icu patients will be followed over their hospital stay over a maximum period of 6 months No
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