HyponatremiaNCT02399358
Factors Associated With Hyponatremia Induced by High-dose Cyclophosphamide
An observational study of Hyponatremia, run by Diego Hernan Giunta, MD at 1 site in Argentina.
Trial summary
Prospoctive cohort of high-dose cyclophosphamide exposed patients. With active estandardize screening of hyponatremia development in the follow up period. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hyponatremia
- Type of treatment
- Injection or infusion
- How many people
- 200 participants
- Where
- 1 siteArgentina
- Study dates
- Dec 2015to Nov 2017
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult patients (Over 18 years) admitted for high-dose cyclophosphamide.
Who may be able to join
- Adult patients (over 18 years) who were admitted to the Hematology / Oncology and Medical Clinic Hospital Italiano de Buenos Aires infusion of high-dose cyclophosphamide for conducting MSCH prior BMT, GATLA and HyperCVAD in the period 2015-2017.
Who cannot join
- Refusal to participate or to the process of informed consent.
Trial locations and contacts
1 site in 1 country.
Argentina1 site
Hospital Italiano de Buenos Aires, Peron 4190
Buenos Aires, Buenos Aires F.D., C1199ABB
Diego H Giunta, MD, +54 9 11 5825-6489, diego.giunta@hospitalitaliano.org.ar
Cristina M Elizondo, MD, +54 9 11 5745-8048, cristina.elizondo@hospitalitaliano.org.ar
About this study
Official title: Factors Associated With Hyponatremia Induced by High-dose Cyclophosphamide: Prospective Cohort Study
Prospoctive cohort of high-dose cyclophosphamide exposed patients. With active estandardize screening of hyponatremia development in the follow up period.
Read the detailed description
Primary objectives
- To identify the factors associated with the development of hyponatremia in patients receiving high-dose cyclophosphamide (2.5 grams or more).
- Generate and validate a predictive score of developing hyponatremia high-dose cyclophosphamide.
- To estimate the incidence of hyponatremia in patients undergoing high-dose cyclophosphamide.
Study design. Observational prospective cohort study of Patients after infusion of high-dose cyclophosphamide. Follow up period will be from cyclophosphamide infusion until one month after hospital discharge.
- Conditions
- Hyponatremia
- Keywords
- Drug induced Hyponatremia, Cyclophosphamide, Hyponatremia, Cyclophosphamide induced Hyponatremia
- Medical subject headings
- Hyponatremia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| High-dose Cyclophosphamide | Patients requiring infusion of high-dose cyclophosphamide in the period 2015-2017 will be included. After informed consent, patients will de follow up from the infusion of cyclophosphamide to 30 days after hospital discharge. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hyponatremia
Hyponatremia, measured as any value sodium after infusion and defined as positive if sodium less than 135 mEq / l (Yes / No, dichotomous categorical variable). For the incidence of hyponatremia is only included in the calculation hionatremia patients with normal sodium before infusion.
Measured: Between 6 and 8 hours after the infusion of cyclophosphamide is performed.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Mar 2015 (estimated)
- Study startDec 2015
- Primary completionJun 2017 (estimated)
- Study completionNov 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HyponatremiaStudies 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
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Diego Hernan Giunta, MD
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Diego Hernan Giunta, MD, Hospital Italiano de Buenos Aires
- Investigators
- Fernando Warley, MD, Principal investigator, Hospital Italiano de Buenos AiresBelen Bonella, MD, Principal investigator, Hospital Italiano de Buenos AiresVictoria Otero, MD, Principal investigator, Hospital Italiano de Buenos AiresBruno L Ferreyro, MD, Principal investigator, Hospital Italiano de Buenos Aires
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02399358
- Sponsor's protocol ID
- 2439
- Status last verified
- Dec 2015
- First submitted
- 22 Mar 2015
- Last updated
- 17 Dec 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Factors Associated With Hyponatremia Induced by High-dose Cyclophosphamide: Prospective Cohort Study
- ClinicalTrials.gov ID
- NCT02399358
- Acronym / sponsor ID
- 2439
- Conditions
- Hyponatremia
- Keywords
- Drug induced Hyponatremia, Cyclophosphamide, Hyponatremia, Cyclophosphamide induced Hyponatremia
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Diego Hernan Giunta, MDUniversity, hospital or other
- Study start
- Dec 2015
- Primary completion
- Jun 2017 (estimated)
- Study completion
- Nov 2017 (estimated)
- First posted
- 26 Mar 2015 (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.
Prospoctive cohort of high-dose cyclophosphamide exposed patients. With active estandardize screening of hyponatremia development in the follow up period.
Detailed description
Primary objectives
- To identify the factors associated with the development of hyponatremia in patients receiving high-dose cyclophosphamide (2.5 grams or more).
- Generate and validate a predictive score of developing hyponatremia high-dose cyclophosphamide.
- To estimate the incidence of hyponatremia in patients undergoing high-dose cyclophosphamide.
Study design. Observational prospective cohort study of Patients after infusion of high-dose cyclophosphamide. Follow up period will be from cyclophosphamide infusion until one month after hospital discharge.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| High-dose Cyclophosphamide | – | –Patients requiring infusion of high-dose cyclophosphamide in the period 2015-2017 will be included. After informed consent, patients will de follow up from the infusion of cyclophosphamide to 30 days after hospital discharge. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients (Over 18 years) admitted for high-dose cyclophosphamide.
Key inclusion criteria (1 listed)
- Adult patients (over 18 years) who were admitted to the Hematology / Oncology and Medical Clinic Hospital Italiano de Buenos Aires infusion of high-dose cyclophosphamide for conducting MSCH prior BMT, GATLA and HyperCVAD in the period 2015-2017.
Key exclusion criteria (1 listed)
- Refusal to participate or to the process of informed consent.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Hyponatremia
Time frame: Between 6 and 8 hours after the infusion of cyclophosphamide is performed.
Hyponatremia, measured as any value sodium after infusion and defined as positive if sodium less than 135 mEq / l (Yes / No, dichotomous categorical variable). For the incidence of hyponatremia is only included in the calculation hionatremia patients with normal sodium before infusion.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Dec 2015.
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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.
Fernando Warley, MD principal investigator
Hospital Italiano de Buenos Aires
Belen Bonella, MD principal investigator
Hospital Italiano de Buenos Aires
Victoria Otero, MD principal investigator
Hospital Italiano de Buenos Aires
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hyponatremia, run by Diego Hernan Giunta, MD at 1 site in Argentina.
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 1 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 17 Dec 2015. 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 Argentina. 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 Fernando Warley, MD (+54 9 11 61541958, fernando.warley@hospitalitaliano.org.ar), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hyponatremia (time frame: Between 6 and 8 hours after the infusion of cyclophosphamide is performed.). 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 17 Dec 2015.