The Influence of Preoperative Cardiopulmonary Capacity on the Perioperative Lactate Level

Sensitivity Training Groups Clinical Trial

Official title:

The Influence of Preoperative Cardiopulmonary Capacity Mesured in MET's (Metabolic Equivalents) on the Perioperative Lactate Level

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01819337
• Other study ID #: Lactate1
• 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

Related Conditions & MeSH terms

• Complication, Cardio-respiratory
• Sensitivity Training Groups

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