Behaviour of Intravenous Solutions in Obese Patients Under General Anesthesia

November 18, 2012 updated by: Maria Victoria Hernandez Martinez, National Institute of Medical Sciences and Nutrition, Salvador Zubiran

Colloid Volume Kinetics in Morbidly Obese Patients Under General Anaesthesia

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 Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

12

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Maria V Hernandez Martinez, M.D.
  • Phone Number: 5020/5021 52 55 54 87 09 00
  • Email: mvictoria20@me.com

Study Contact Backup

  • Name: Guillermo Dominguez Cherit, M.D.
  • Phone Number: 5020/5021 52 55 54 87 09 00
  • Email: guidom@prodigy.net.mx

Study Locations

  • Mexico
    • Distrito Federal
      • Mexico City, Distrito Federal, Mexico, 14000
        • Recruiting
        • National Institute of Medical Sciences, Salvador Zubiran
        • Sub-Investigator:
          • Bernardo Gutierrez Sougarret, M.D.
        • Sub-Investigator:
          • Guillermo Dominguez Cherit, M.D.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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
  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
OTHER: Tetrastarch (130/0.4)
In 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.
Other: Tetrastarch (130/0.4)
Other Names:
  • Voluven 6%

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
90 minutes after beginning of the infusion

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Institute of Medical Sciences and Nutrition, Salvador Zubiran

Investigators

  • 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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2012

Primary Completion (ANTICIPATED)

December 1, 2012

Study Completion (ANTICIPATED)

December 1, 2012

Study Registration Dates

First Submitted

July 25, 2012

First Submitted That Met QC Criteria

July 25, 2012

First Posted (ESTIMATE)

July 27, 2012

Study Record Updates

Last Update Posted (ESTIMATE)

November 20, 2012

Last Update Submitted That Met QC Criteria

November 18, 2012

Last Verified

November 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • REF.343

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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