ObesityNCT01652131
Behaviour of Intravenous Solutions in Obese Patients Under General Anesthesia
A study testing Tetrastarch (130/0.4) in people with Obesity and Obesity, Morbid, run by National Institute of Medical Sciences and Nutrition, Salvador Zubiran at 1 site in Mexico.
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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Obesity, Obesity, Morbid
- What is being tested?
- Tetrastarch (130/0.4)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteMexico
- Study dates
- May 2012to Dec 2012
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- clinical diagnosis of obesity (IMC >35kg/m2) that will be treated with gastrojejunal laparoscopic bypass
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Mexico1 site, 1 recruiting
- Recruiting
National Institute of Medical Sciences, Salvador Zubiran
Mexico City, Mexico City, 14000
Bernardo Gutierrez Sougarret, M.D.
Guillermo Dominguez Cherit, M.D.
About this study
Official title: 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.
- Conditions
- Obesity, Obesity, Morbid
- Being tested
- Tetrastarch (130/0.4)
- Keywords
- general anesthesia, volume kinetics
- Medical subject headings
- Obesity, Obesity, Morbid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tetrastarch (130/0.4)Other
Also called Voluven 6%
| Study group | Role | What they receive |
|---|---|---|
| Tetrastarch (130/0.4) | Other | 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. Receives: Other: Tetrastarch (130/0.4) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 90 minutes after beginning of the infusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jul 2012 (estimated)
- Study startMay 2012
- Primary completionDec 2012 (estimated)
- Study completionDec 2012 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 12 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Institute of Medical Sciences and Nutrition, Salvador Zubiran
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Maria Victoria Hernandez Martinez, National Institute of Medical Sciences and Nutrition, Salvador Zubiran
- Investigators
- Miguel F Herrera Hernandez, MD MSc PhD, Study director, National Institute of Medical Sciences, Salvador ZubiranMaria V Hernandez Martinez, M.D., Principal investigator, National Institute of Medical Sciences, Salvador Zubiran
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01652131
- Sponsor's protocol ID
- REF.343
- Status last verified
- Nov 2012
- First submitted
- 25 Jul 2012
- Last updated
- 20 Nov 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 20 Nov 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Colloid Volume Kinetics in Morbidly Obese Patients Under General Anaesthesia
- ClinicalTrials.gov ID
- NCT01652131
- Acronym / sponsor ID
- REF.343
- Conditions
- Obesity, Obesity, Morbid
- Keywords
- general anesthesia, volume kinetics
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 12 participants (estimated)
- Lead sponsor
- National Institute of Medical Sciences and Nutrition, Salvador ZubiranUniversity, hospital or other
- Study start
- May 2012
- Primary completion
- Dec 2012 (estimated)
- Study completion
- Dec 2012 (estimated)
- First posted
- 27 Jul 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Tetrastarch (130/0.4) | Other | 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. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- clinical diagnosis of obesity (IMC >35kg/m2) that will be treated with gastrojejunal laparoscopic bypass
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Tetrastarch (130/0.4)Also: Voluven 6% | Other | Tetrastarch (130/0.4) |
Primary outcome
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Nov 2012.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Miguel F Herrera Hernandez, MD MSc PhD study director
National Institute of Medical Sciences, Salvador Zubiran
Maria V Hernandez Martinez, M.D. principal investigator
National Institute of Medical Sciences, Salvador Zubiran
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Tetrastarch (130/0.4) in people with Obesity and Obesity, Morbid, run by National Institute of Medical Sciences and Nutrition, Salvador Zubiran at 1 site in Mexico.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 20 Nov 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Mexico. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Maria V Hernandez Martinez, M.D. (52 55 54 87 09 00 ext. 5020/5021, mvictoria20@me.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Nov 2012.