Behaviour of Intravenous Solutions in Obese Patients Under General Anesthesia
|ClinicalTrials.gov Identifier: NCT01652131|
Recruitment Status : Unknown
Verified November 2012 by Maria Victoria Hernandez Martinez, National Institute of Medical Sciences and Nutrition, Salvador Zubiran.
Recruitment status was: Recruiting
First Posted : July 27, 2012
Last Update Posted : November 20, 2012
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 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|
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%
- 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
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01652131
|Contact: Maria V Hernandez Martinez, M.D.||52 55 54 87 09 00 ext email@example.com|
|Contact: Guillermo Dominguez Cherit, M.D.||52 55 54 87 09 00 ext firstname.lastname@example.org|
|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.|
|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|