PolyuriaNCT06535386
Polyuria Associated With Dexmedetomidine in Operating Room
An observational study of Polyuria, run by Hospital Privado de Comunidad de Mar del Plata.
Trial summary
Dexmedetomidine is an a2-adrenergic receptor agonist drug, widely used in intensive care for the sedation of patients on mechanical ventilation, as well as in the operating room during invasive procedures and during general anesthesia. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Polyuria
- What is being tested?
- Dexmedetomidine 0.004 MG/ML
- How many people
- 150 participants
- Where
- No sites listed yet
- Study dates
- 10 Aug 2024to 10 Jan 2025
- Phase
- Observational
- 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 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients of both sex and age, over 18-year-old, ASA I - II - III scheduled for high complexity surgery under general anesthesia who receive dexmedetomidine intra-operatively and who require arterial line and urinary catheter, for a period of 4 months.
Who may be able to join
- Age > 18 years old
- Scheduled surgery
- Dexmedetomidine in boluses and/or continuous infusion during intra-operative period
- Patients who require arterial line and urinary catheter
Who cannot join
- Chronic renal disease.
- eGFR < 60 ml/min/1.73m2 for more than 3 months of evolution.
- Emergency or unscheduled surgeries.
- Central nervous system disease at the sellar or suprasellar level.
- Patients receiving diuretics.
- Liver cirrhosis.
- Adrenal gland disease.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Incidence of Polyuria Associated With Dexmedetomidine During the Intra-operative Period
Dexmedetomidine is an a2-adrenergic receptor agonist drug, widely used in intensive care for the sedation of patients on mechanical ventilation, as well as in the operating room during invasive procedures and during general anesthesia. It also has anti-inflammatory properties and reduces the need for opioids and benzodiazepines, which leads to a lower incidence of delirium associated with these drugs.
Among the frequent adverse effects associated with the administration of dexmedetomidine we can find bradycardia and hypotension, while some studies carried out in animals have shown that it can increase the diuretic rate.
Read more
Polyuria related to pharmacological agonism of a2-adrenergic receptors has been described in vitro and in studies performed in animal models, and is believed to be the result of functional antagonism of arginine vasopressin. Despite its widespread use as a sedative and adjunctive anesthetic, there are very few reports in the literature of dexmedetomidine-related polyuria in humans.
Currently there are no reports in the literature on the incidence of polyuria induced by the intraoperative administration of dexmedetomidine.
Read the detailed description
This is a prospective, observational study designed to determine the incidence of polyuria, defined as urine output greater than 150 ml/h or 3 ml/kg/h, associated with the administration of dexmedetomidine during the intraoperative period.
The investigators will prospectively and consecutively study all patients scheduled for high complexity surgery under general anesthesia for a period of 4 months.
The diuretic rate will be quantified in ml/hour. A urine sample will be taken two hours after the start of surgery to assess sodium and urinary density, and an arterial blood sample will be taken to determine serum sodium.
Hydration will be recorded in milliliters per hour, detailing the type of solution used.
All data obtained will be captured in a RedCap data collection form.
- Conditions
- Polyuria
- Being tested
- Dexmedetomidine 0.004 MG/ML
- Keywords
- dexmedetomidine, polyuria, anesthesia
- Medical subject headings
- Polyuria
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dexmedetomidine 0.004 MG/MLDrug
Incidence of polyuria during the intraoperative period, associated with dexmedetomidine .
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of polyuria associated with the administration of dexmedetomidine
Determine the incidence of polyuria defined as urine output greater than 150 ml/h or 3 ml/kg/h associated with the administration of dexmedetomidine during the intraoperative period in patients scheduled for highly complex surgery
Measured: 3 hours
Secondary outcomes (1)
determine if the appearance of polyuria is associated with other factors
Determine if there is any correlation between the appearance of polyuria associated with the administration of dexmedetomidine and age, sex, type of surgery, other anesthetic drugs, and esophageal temperature.
Measured: 3 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Aug 2024
- Study start10 Aug 2024 (estimated)
- Primary completion15 Dec 2024 (estimated)
- Study completion10 Jan 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PolyuriaStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospital Privado de Comunidad de Mar del Plata
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Cecilia Acosta, MD, Principal investigator, Hospital Privado de Comunidad
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06535386
- Sponsor's protocol ID
- HPC
- Status last verified
- Jul 2024
- First submitted
- 30 Jul 2024
- Last updated
- 7 Aug 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Incidence of Polyuria Associated With Dexmedetomidine During the Intra-operative Period
- ClinicalTrials.gov ID
- NCT06535386
- Acronym / sponsor ID
- HPC
- Conditions
- Polyuria
- Keywords
- dexmedetomidine, polyuria, anesthesia
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Hospital Privado de Comunidad de Mar del PlataUniversity, hospital or other
- Study start
- 10 Aug 2024 (estimated)
- Primary completion
- 15 Dec 2024 (estimated)
- Study completion
- 10 Jan 2025 (estimated)
- First posted
- 2 Aug 2024 (actual)
- 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.
Dexmedetomidine is an a2-adrenergic receptor agonist drug, widely used in intensive care for the sedation of patients on mechanical ventilation, as well as in the operating room during invasive procedures and during general anesthesia. It also has anti-inflammatory properties and reduces the need for opioids and benzodiazepines, which leads to a lower incidence of delirium associated with these drugs.
Among the frequent adverse effects associated with the administration of dexmedetomidine we can find bradycardia and hypotension, while some studies carried out in animals have shown that it can increase the diuretic rate.
Polyuria related to pharmacological agonism of a2-adrenergic receptors has been described in vitro and in studies performed in animal models, and is believed to be the result of functional antagonism of arginine vasopressin. Despite its widespread use as a sedative and adjunctive anesthetic, there are very few reports in the literature of dexmedetomidine-related polyuria in humans.
Currently there are no reports in the literature on the incidence of polyuria induced by the intraoperative administration of dexmedetomidine.
Detailed description
This is a prospective, observational study designed to determine the incidence of polyuria, defined as urine output greater than 150 ml/h or 3 ml/kg/h, associated with the administration of dexmedetomidine during the intraoperative period.
The investigators will prospectively and consecutively study all patients scheduled for high complexity surgery under general anesthesia for a period of 4 months.
The diuretic rate will be quantified in ml/hour. A urine sample will be taken two hours after the start of surgery to assess sodium and urinary density, and an arterial blood sample will be taken to determine serum sodium.
Hydration will be recorded in milliliters per hour, detailing the type of solution used.
All data obtained will be captured in a RedCap data collection form.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients of both sex and age, over 18-year-old, ASA I - II - III scheduled for high complexity surgery under general anesthesia who receive dexmedetomidine intra-operatively and who require arterial line and urinary catheter, for a period of 4 months.
Key inclusion criteria (4 listed)
- Age > 18 years old
- Scheduled surgery
- Dexmedetomidine in boluses and/or continuous infusion during intra-operative period
- Patients who require arterial line and urinary catheter
Key exclusion criteria (7 listed)
- Chronic renal disease.
- eGFR < 60 ml/min/1.73m2 for more than 3 months of evolution.
- Emergency or unscheduled surgeries.
- Central nervous system disease at the sellar or suprasellar level.
- Patients receiving diuretics.
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 |
|---|---|---|
| Dexmedetomidine 0.004 MG/MLIncidence of polyuria during the intraoperative period, associated with dexmedetomidine . | Drug | – |
Primary outcome
Incidence of polyuria associated with the administration of dexmedetomidine
Time frame: 3 hours
Determine the incidence of polyuria defined as urine output greater than 150 ml/h or 3 ml/kg/h associated with the administration of dexmedetomidine during the intraoperative period in patients scheduled for highly complex surgery
1 secondary outcome
determine if the appearance of polyuria is associated with other factors
Time frame: 3 hours
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Aug 2024.
- Individual participant dataSharing planned: Undecided
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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.
Cecilia Acosta, MD principal investigator
Hospital Privado de Comunidad
Questions about this trial
What is this clinical trial studying?
An observational study of Polyuria, run by Hospital Privado de Comunidad de Mar del Plata.
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 4 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 7 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
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 Cecilia M Acosta, MD (542234990074, ceacosta77@icloud.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of polyuria associated with the administration of dexmedetomidine (time frame: 3 hours). 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 7 Aug 2024.