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Clinical Trials/NCT01652131
NCT01652131UnknownNot Applicable

Colloid Volume Kinetics in Morbidly Obese Patients Under General Anaesthesia

National Institute of Medical Sciences and Nutrition, Salvador Zubiran1 site in 1 country12 target enrollmentStarted: May 1, 2012Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Sponsor
Enrollment
12
Locations
1
Primary Endpoint
description of colloid volume kinetics in obese patients after the infusion of Tetrastarch (130/0.4)

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Na
Intervention Model
Single Group
Masking
None

Eligibility Criteria

Ages
18 Years to 70 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • clinical diagnosis of obesity (IMC >35kg/m2) that will be treated with gastrojejunal laparoscopic bypass

Exclusion Criteria

  • Renal failure KDOQI >3
  • Cardiac failure NYHA III-IV
  • 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.

Outcomes

Primary Outcomes

description of colloid volume kinetics in obese patients after the infusion of Tetrastarch (130/0.4)

Time Frame: 90 minutes after beginning of the infusion

different kinetic parameters will be used to asses the behavior of the colloid solution

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor
National Institute of Medical Sciences and Nutrition, Salvador Zubiran
Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Maria Victoria Hernandez Martinez

M.D.

National Institute of Medical Sciences and Nutrition, Salvador Zubiran

Study Sites (1)

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