Sensitivity Training GroupsNCT01819337
The Influence of Preoperative Cardiopulmonary Capacity on the Perioperative Lactate Level
An observational study of Sensitivity Training Groups and Complication, Cardio-respiratory, run by University of Witten/Herdecke at 1 site in Germany.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Sensitivity Training Groups, Complication, Cardio-respiratory
- How many people
- 1,502 participants
- Where
- 1 siteGermany
- Study dates
- Mar 2013to Aug 2013
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: All patients undergoing elective/urgent or emergency surgery
Who may be able to join
- Age > 18 years
Who cannot join
- Cardiac surgery
Trial locations and contacts
1 site in 1 country.
Germany1 site
Helios Klinikum Wuppertal
Wuppertal, North Rhine-Westphalia, 42283
About this study
Official title: The Influence of Preoperative Cardiopulmonary Capacity Mesured in MET's (Metabolic Equivalents) on the Perioperative Lactate Level
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.
Read the detailed 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.
What is being measured
The primary outcome is the main question the study is designed to answer.
lactate - venous blood gas analysis
mmol/l
Measured: 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
Measured: icu patients will be followed over their hospital stay over a maximum period of 6 months
hemoglobin - venous blood gas analysis
g/dl
Measured: hemoglobin will be measured at anaesthesia induction and anesthesia termination - the average time frame is 2 hours
icu ventilation time
hours/days
Measured: icu patients will be followed over their hospital stay over a maximum period of 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2013 (estimated)
- Study startMar 2013
- Primary completionApr 2013
- Study completionAug 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sensitivity Training GroupsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,502 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Witten/Herdecke
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Armin Zagler, University of Witten/Herdecke
- Investigators
- Gerhard Schneider, Prof., Study chair, Dept. Anaesthesiology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01819337
- Sponsor's protocol ID
- Lactate1
- Status last verified
- Sep 2013
- First submitted
- 8 Feb 2013
- Last updated
- 17 Sep 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Sep 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Influence of Preoperative Cardiopulmonary Capacity Mesured in MET's (Metabolic Equivalents) on the Perioperative Lactate Level
- ClinicalTrials.gov ID
- NCT01819337
- Acronym / sponsor ID
- Lactate1
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,502 participants (actual)
- Lead sponsor
- University of Witten/HerdeckeUniversity, hospital or other
- Study start
- Mar 2013
- Primary completion
- Apr 2013 (actual)
- Study completion
- Aug 2013 (actual)
- First posted
- 27 Mar 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- All patients undergoing elective/urgent or emergency surgery
Key inclusion criteria (1 listed)
- Age > 18 years
Key exclusion criteria (1 listed)
- Cardiac surgery
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
lactate - venous blood gas analysis
Time frame: venous lactate will be measured at anaesthesia induction and anesthesia termination - the average time frame is 2 hours
mmol/l
3 secondary outcomes
icu in hospital mortality
Time frame: icu patients will be followed over their hospital stay over a maximum period of 6 months
hemoglobin - venous blood gas analysis
Time frame: hemoglobin will be measured at anaesthesia induction and anesthesia termination - the average time frame is 2 hours
icu ventilation time
Time frame: icu patients will be followed over their hospital stay over a maximum period of 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Sep 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gerhard Schneider, Prof. study chair
Dept. Anaesthesiology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Sensitivity Training Groups and Complication, Cardio-respiratory, run by University of Witten/Herdecke at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Sep 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
lactate - venous blood gas analysis (time frame: venous lactate will be measured at anaesthesia induction and anesthesia termination - the average time frame is 2 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Sep 2013.