Acute Kidney InjuryNCT05221216
Retrospective Observational Study of Cotrimoxazole Dosing in Intensive Care Unit
An observational study of Acute Kidney Injury, run by Centre Hospitalier Universitaire de Saint Etienne at 1 site in France.
Trial summary
Trimethoprim/sulfamethoxazole (TMP/SMX, cotrimoxazole) is the first-line therapy for Pneumocystis jirovecii pneumonia and bacterial infections in critically ill patients, where acute kidney injury (AKI) and renal replacement therapy (RRT) are regularly observed. Both may change half-life and subsequent concentrations. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Kidney Injury
- What is being tested?
- Collect data of medical record
- How many people
- 5 participants
- Where
- 1 siteFrance
- Study dates
- 15 Oct 2021to 15 Nov 2021
- 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: Patient hospitalized in Intensive Care Units between October 2020 and July 2021 with infection treated with cotrimoxazole will be included.
Who may be able to join
- Patient hospitalized in Intensive Care Units between October 2020 and July 2021 with infection treated with cotrimoxazole
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Single-center Retrospective Observational Study of Cotrimoxazole Dosing in Intensive Care Unit
Trimethoprim/sulfamethoxazole (TMP/SMX, cotrimoxazole) is the first-line therapy for Pneumocystis jirovecii pneumonia and bacterial infections in critically ill patients, where acute kidney injury (AKI) and renal replacement therapy (RRT) are regularly observed. Both may change half-life and subsequent concentrations. Specifically, Trimethoprim (TMP) is eliminated renally, whereas sulfamethoxazole (SMX) elimination is 80%metabolic/20%renal. Despite decades of cotrimoxazole use, data in acute kidney injury (AKI) are scarce and no consensus on dosing strategy has been established. Besides, pharmacodynamic parameter has not been determined, leading to an uncertainty on the dosing regimen.
Read the detailed description
The objective is to compare the plasma concentrations of patients with acute renal failure (ARF) or requiring extra renal replacement therapy (RRT) with those of patients without these characteristics to look for differences in concentration.
- Conditions
- Acute Kidney Injury
- Being tested
- Collect data of medical record
- Keywords
- cotrimoxazole, Acute Kidney Injury, renal replacement therapy, pharmacodynamic
- Medical subject headings
- Acute Kidney Injury
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Collect data of medical recordOther
Collect data of medical record: plasma concentrations of cotrimoxazole, demographic data (age, weight, height), data on the use of an extra renal replacement therapy (RRT) (date, type, number of sessions and duration of extra renal replacement therapy (RRT))
| Study group | Role | What they receive |
|---|---|---|
| patients in Intensive Care unit | patients in Intensive Care unit with infection treated with cotrimoxazole will be included. Data will be collected of medical record. Receives: Other: Collect data of medical record |
What is being measured
The primary outcome is the main question the study is designed to answer.
plasma concentrations of cotrimoxazole (mg/l)
pharmacokinetic cotrimoxazole
Measured: From the antibiotic initiation until the patient is discharged from the ICU with a maximal time frame of 10 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Feb 2022
- Study start15 Oct 2021
- Primary completion15 Nov 2021
- Study completion15 Nov 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Kidney InjuryStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de Saint EtienneThe sponsor's other registered studies.
- 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
- Retrospective
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sophie PERINEL RAGEY, MD, Principal investigator, Centre Hospitalier Universitaire de Saint Etienne
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05221216
- Sponsor's protocol ID
- IRBN1452021/CHUSTE
- Status last verified
- Jan 2022
- First submitted
- 31 Dec 2021
- Last updated
- 2 Feb 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Single-center Retrospective Observational Study of Cotrimoxazole Dosing in Intensive Care Unit
- ClinicalTrials.gov ID
- NCT05221216
- Acronym / sponsor ID
- IRBN1452021/CHUSTE
- Conditions
- Acute Kidney Injury
- Keywords
- cotrimoxazole, Acute Kidney Injury, renal replacement therapy, pharmacodynamic
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 5 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de Saint EtienneUniversity, hospital or other
- Study start
- 15 Oct 2021 (actual)
- Primary completion
- 15 Nov 2021 (actual)
- Study completion
- 15 Nov 2021 (actual)
- First posted
- 2 Feb 2022 (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.
Trimethoprim/sulfamethoxazole (TMP/SMX, cotrimoxazole) is the first-line therapy for Pneumocystis jirovecii pneumonia and bacterial infections in critically ill patients, where acute kidney injury (AKI) and renal replacement therapy (RRT) are regularly observed. Both may change half-life and subsequent concentrations. Specifically, Trimethoprim (TMP) is eliminated renally, whereas sulfamethoxazole (SMX) elimination is 80%metabolic/20%renal. Despite decades of cotrimoxazole use, data in acute kidney injury (AKI) are scarce and no consensus on dosing strategy has been established. Besides, pharmacodynamic parameter has not been determined, leading to an uncertainty on the dosing regimen.
Detailed description
The objective is to compare the plasma concentrations of patients with acute renal failure (ARF) or requiring extra renal replacement therapy (RRT) with those of patients without these characteristics to look for differences in concentration.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| patients in Intensive Care unit | – | Other: Collect data of medical recordpatients in Intensive Care unit with infection treated with cotrimoxazole will be included. Data will be collected of medical record. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patient hospitalized in Intensive Care Units between October 2020 and July 2021 with infection treated with cotrimoxazole will be included.
Key inclusion criteria (1 listed)
- Patient hospitalized in Intensive Care Units between October 2020 and July 2021 with infection treated with cotrimoxazole
Key exclusion criteria (1 listed)
- None
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 |
|---|---|---|
| Collect data of medical recordCollect data of medical record: plasma concentrations of cotrimoxazole, demographic data (age, weight, height), data on the use of an extra renal replacement therapy (RRT) (date, type, number of sessions and duration of extra renal replacement therapy (RRT)) | Other | patients in Intensive Care unit |
Primary outcome
plasma concentrations of cotrimoxazole (mg/l)
Time frame: From the antibiotic initiation until the patient is discharged from the ICU with a maximal time frame of 10 weeks
pharmacokinetic cotrimoxazole
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Feb 2022.
- Individual participant dataSharing planned: No
Related trials for Acute Kidney Injury
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Early Biomarker Kidney Injury Assessment After Acumen Directed Fluid Management in Cardiac Surgery
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Acute Kidney Injury and Ultra-endurance Running
AKI (Acute Kidney Injury) Due to Trauma
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WIN Ratio Analysis to Determine a Strategy of Non- Invasive SUpport for Respiratory Failure in the EmeRgency Department
Acute Hypoxic Respiratory Failure, Acute Respiratory Distress Syndrome (ARDS)
Not yet recruitingObservational study
Diastolic Shock Index for Predicting Hemodynamic Instability During Continuous Renal Replacement Therapy
Acute Kidney Injury, Hypotension (MeSH: D007022)
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.
Sophie PERINEL RAGEY, MD principal investigator
Centre Hospitalier Universitaire de Saint Etienne
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 Acute Kidney Injury, run by Centre Hospitalier Universitaire de Saint Etienne at 1 site in France.
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: finished, as of the sponsor's last update on 2 Feb 2022. 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 France. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
plasma concentrations of cotrimoxazole (mg/l) (time frame: From the antibiotic initiation until the patient is discharged from the ICU with a maximal time frame of 10 weeks). 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 2 Feb 2022.