Behaviour of Intravenous Solutions in Obese Patients Under General Anesthesia
Colloid Volume Kinetics in Morbidly Obese Patients Under General Anaesthesia
1 other identifier
interventional
12
1 country
1
Brief Summary
There is no objective evidence of how long intravenous solutions remain inside venous blood vessels after they have been administered, therefore there is no definite guideline of how to administer them in the preoperative setting. Besides, obese patients represent a particular group of subjects as they theoretically with-hold a constant inflammatory response and that would modify the way solutions behave intravenously, that is how long they remain inside. Having said this, we wish to describe the way colloid solutions behave in this group of patients by taking serial blood samples in 12 obese patients after a colloid infusion, to calculate plasma dilution curves based on hemoglobin dilution and therefore infer the time it remains intravascularly. All this in the hope this information will help, in the near future, to establish a more objective way to use these solutions and avoid possible complications due to over-administration.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable obesity
Started May 2012
Shorter than P25 for not_applicable obesity
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2012
CompletedFirst Submitted
Initial submission to the registry
July 25, 2012
CompletedFirst Posted
Study publicly available on registry
July 27, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2012
CompletedNovember 20, 2012
November 1, 2012
7 months
July 25, 2012
November 18, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
description of colloid volume kinetics in obese patients after the infusion of Tetrastarch (130/0.4)
different kinetic parameters will be used to asses the behavior of the colloid solution
90 minutes after beginning of the infusion
Study Arms (1)
Tetrastarch (130/0.4)
OTHERIn obese patients candidates to laparoscopic gastrojejunal bypass an infusion of Tetrastarch (130/0.4)) of 15mL/kg (of corrected weight) will be initiated after protocoled induction of general anesthesia. Blood samples will be taken at time 0 (after induction of anesthesia and before initiating infusion) and then every 5 minutes for half an hour and then every 15 minutes up to 90 minutes. Blood samples will be processed in the Institution's laboratory. Urine will be measured at the end of the intervention. With these data kinetic parameters will be estimated for each patient.
Interventions
Eligibility Criteria
You may qualify if:
- clinical diagnosis of obesity (IMC \>35kg/m2) that will be treated with gastrojejunal laparoscopic bypass
You may not qualify if:
- Renal failure KDOQI \>3
- Cardiac failure NYHA III-IV
- Sepsis
- Allergy to tetrastarch
- Allergy to any of the anesthetic medication that is to be used in the protocol previously established
- Patients in which vasoactive drugs are used
- Patients in which the blood samples are completed.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
National Institute of Medical Sciences, Salvador Zubiran
Mexico City, Mexico City, 14000, Mexico
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Miguel F Herrera Hernandez, MD MSc PhD
National Institute of Medical Sciences, Salvador Zubiran
- PRINCIPAL INVESTIGATOR
Maria V Hernandez Martinez, M.D.
National Institute of Medical Sciences, Salvador Zubiran
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- M.D.
Study Record Dates
First Submitted
July 25, 2012
First Posted
July 27, 2012
Study Start
May 1, 2012
Primary Completion
December 1, 2012
Study Completion
December 1, 2012
Last Updated
November 20, 2012
Record last verified: 2012-11