Behaviour of Intravenous Solutions in Obese Patients Under General Anesthesia

Study Description

Go to 

Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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.

Condition or disease	Intervention/treatment	Phase
Obesity; Obesity, Morbid	Other: Tetrastarch (130/0.4)	Not Applicable

Study Design

Go to 

Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Study Type :	Interventional (Clinical Trial)
Estimated Enrollment :	12 participants
Intervention Model:	Single Group Assignment
Masking:	None (Open Label)
Official Title:	Colloid Volume Kinetics in Morbidly Obese Patients Under General Anaesthesia
Study Start Date :	May 2012
Estimated Primary Completion Date :	December 2012
Estimated Study Completion Date :	December 2012

Arms and Interventions

Go to 

Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm

Intervention/treatment

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%

Outcome Measures

Go to 

Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :

1. 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

Eligibility Criteria

Go to 

Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Ages Eligible for Study:	18 Years to 70 Years (Adult, Senior)
Sexes Eligible for Study:	All
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

Go to 

Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

Go to 

Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations 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
First Posted:	July 27, 2012
Last Update Posted:	November 20, 2012
Last Verified:	November 2012

Keywords provided by Maria Victoria Hernandez Martinez, 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