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Behaviour of Intravenous Solutions in Obese Patients Under General Anesthesia

The recruitment status of this study is unknown because the information has not been verified recently.
Verified November 2012 by National Institute of Medical Sciences and Nutrition, Salvador Zubiran.
Recruitment status was  Recruiting
Sponsor:
Information provided by (Responsible Party):
Maria Victoria Hernandez Martinez, National Institute of Medical Sciences and Nutrition, Salvador Zubiran
ClinicalTrials.gov Identifier:
NCT01652131
First received: July 25, 2012
Last updated: November 18, 2012
Last verified: November 2012
History of Changes
  Purpose

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.


Condition Intervention
Obesity
Obesity, Morbid
 Other: Tetrastarch (130/0.4)

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Official Title: Colloid Volume Kinetics in Morbidly Obese Patients Under General Anaesthesia

Further study details as provided by National Institute of Medical Sciences and Nutrition, Salvador Zubiran:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
    different kinetic parameters will be used to asses the behavior of the colloid solution
Estimated Enrollment: 12
Study Start Date: May 2012
Estimated Study Completion Date: December 2012
Estimated Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: Voluven 6%

  Eligibility
Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01652131

Contacts
Contact: Maria V Hernandez Martinez, M.D. 52 55 54 87 09 00 ext 5020/5021 mvictoria20@me.com
Contact: Guillermo Dominguez Cherit, M.D. 52 55 54 87 09 00 ext 5020/5021 guidom@prodigy.net.mx

Locations
Mexico
National Institute of Medical Sciences, Salvador Zubiran Recruiting
Mexico City, Distrito Federal, Mexico, 14000
Sub-Investigator: Bernardo Gutierrez Sougarret, M.D.         
Sub-Investigator: Guillermo Dominguez Cherit, M.D.         
Sponsors and Collaborators
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
  More Information

Responsible Party: Maria Victoria Hernandez Martinez, M.D., National Institute of Medical Sciences and Nutrition, Salvador Zubiran
ClinicalTrials.gov Identifier: NCT01652131     History of Changes
Other Study ID Numbers: REF.343 
Study First Received: July 25, 2012
Last Updated: November 18, 2012
Health Authority: Mexico: Secretaria de Salud

Keywords provided by National Institute of Medical Sciences and Nutrition, Salvador Zubiran:
general anesthesia
volume kinetics

Additional relevant MeSH terms:
Obesity
Obesity, Morbid
Overnutrition
Nutrition Disorders
Overweight
 Body Weight
Signs and Symptoms
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on September 23, 2016