Behaviour of Intravenous Solutions in Obese Patients Under General Anesthesia

Obesity Clinical Trial

Official title:

Colloid Volume Kinetics in Morbidly Obese Patients Under General Anaesthesia

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01652131
• Other study ID #: REF.343
• Status: Recruiting
• Phase: N/A
• First received: July 25, 2012
• Last updated: November 18, 2012
• Start date: May 2012
• Est. completion date: December 2012

Study information

• Verified date: November 2012
• Source: National Institute of Medical Sciences and Nutrition, Salvador Zubiran
• Contact: Maria V Hernandez Martinez, M.D.
• Phone: 52 55 54 87 09 00
• Email: mvictoria20[@]me.com
• Is FDA regulated: No
• Health authority: Mexico: Secretaria de Salud
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 12
• Est. completion date: December 2012
• Est. primary completion date: December 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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 Design

Intervention Model: Single Group Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Obesity
• Obesity, Morbid

Intervention

Other:
• Tetrastarch (130/0.4)

Locations

Country	Name	City	State
Mexico	National Institute of Medical Sciences, Salvador Zubiran	Mexico City	Distrito Federal

Sponsors (1)

Lead Sponsor	Collaborator
National Institute of Medical Sciences and Nutrition, Salvador Zubiran

Country where clinical trial is conducted

Mexico, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No