ICU PatientsNCT03045692
Assessment of Kidney Function for Drug Dosage Adjustments in Critically Ill Patients
A study testing kidney function assessment by 4 hour creatinine clearance and kidney function assessment by creatinine based eGFR in people with ICU Patients, run by Samsung Medical Center.
Trial summary
The aim of the study is to determine if colistin dosage adjustment using 4hr CrCl contribute to better clinical outcomes compared with drug dosage adjustment using eGFR in critical ill patients. In control group, colistin maintenance dosage will be decided using serum creatinine based eGFR (in ml/min). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- ICU Patients
- What is being tested?
- kidney function assessment by 4 hour creatinine clearance and kidney function assessment by creatinine based eGFR
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 172 participants
- Where
- No sites listed yet
- Study dates
- 13 Feb 2017to 30 Apr 2019
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients aged over 18
- Patients in intensive care unit received colistin for the microbiologically documented cases associated with carbapenem-resistant gram negative bacilli.
Who cannot join
- Patients who received colistin empirically.
- Patients who received renal replacement therapy due to acute kidney injury or end-stage renal disease
- Patients whose urine output was less than 0.5cc/kg/hr for 6 hrs
- Patients who underwent hematopoietic stem cell transplantation
- Patients who disagree with this study.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Reliable Methods to Assess Kidney Function for Drug Dosage Adjustments in Critically Ill Patients - Comparison of Timed Clearance of Creatinine and Creatinine Based Estimated GFR
The aim of the study is to determine if colistin dosage adjustment using 4hr CrCl contribute to better clinical outcomes compared with drug dosage adjustment using eGFR in critical ill patients. In control group, colistin maintenance dosage will be decided using serum creatinine based eGFR (in ml/min). In study group, colistin maintenance dosage will be decided using 4hr CrCl.
Read the detailed description
- Screening periods (From 'informed consents' to 'randomization')
- Check of inclusion/exclusion criteria ② Measurement of 4hr CrCl \& eGFR in ml/min
- calculation of maintenance dose ③ Baseline characteristics \& laboratory findings ④ Randomization
- Colistin dosage Loading dose : 5 x body weight (not exceeding 300mg) Maintenance dose (after 12 hours from loading dose) : 2.5 x ([1.5 x GFR] + 30) (divided doses every 12hours), GFR in ml/min During the study period, daily morning serm creatinine levels are measured. Whenever serum creatinine concentration changes by more than 10% compared with baseline, 4hr CrCl will be mearued. At the every time of 4hr CrCl measurements, colistin dose wil be modified according to new GFR values (4hr CrCl in study group, eGFR in control group)
- Blood sampling for Colistin trough level measurement Peripheral blood will be sampled twice between 72 hrs and 144 hours after loading dose, just before colistin infusion. The samples were collected in heparined tubes and centrifuged at 4 °C within 1 hr of collection. The resulting plasma was stored at - 70°C . And two values will be averaged out.
- End of randomization (7 days after colistin initiation) ① Nephrotoxicity ② Treatment outcome microbiological outcome: eradication / no eradication clinical outcome: complete response / partial response / treatment failure
- Conditions
- ICU Patients
- Being tested
- kidney function assessment by 4 hour creatinine clearance, kidney function assessment by creatinine based eGFR
- Keywords
- drug dosing, eGFR, CCr
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
kidney function assessment by 4 hour creatinine clearanceDiagnostic test
4 hour creatinine clearance is used to decide colistin maintenance dosage.
kidney function assessment by creatinine based eGFRDiagnostic test
creatinine based eGFR (which is not revised value with standardized body surface area, that is, 1.73m2) are used to decide colistin maintenance dosage.
| Study group | Role | What they receive |
|---|---|---|
| Control group | Active comparator | creatinine based eGFR (which is not revised value with standardized body surface area, that is, 1.73m2) are used to decide colistin maintenance dosage. Receives: Diagnostic Test: kidney function assessment by creatinine based eGFR |
| Study group | Experimental | 4 hour creatinine clearance is used to decide colistin maintenance dosage. Receives: Diagnostic Test: kidney function assessment by 4 hour creatinine clearance |
What is being measured
The primary outcome is the main question the study is designed to answer.
composite outcome (combination of nephrotoxicity or treatment failure)
Nephrotoxicity means development of AKI (according to RIFLE criterior) Treatment failure menas clinically 'no response'
Measured: 7 days after colistin initiation
Secondary outcomes (5)
colistin trough level, renal clearance of colistin
Measured: 7 days after colistin initiation
ICU stay duration
Measured: till discharge (Max. 3 months)
Total duration of colistin treatment
Measured: till discharge (Max. 3 months)
Need for renal replacement therapy
Measured: 7 days after colistin initiation
In-ICU mortality (infection-attributed mortality)
Measured: till discharge (Max. 3 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Feb 2017 (estimated)
- Study start13 Feb 2017 (estimated)
- Primary completion28 Feb 2019 (estimated)
- Study completion30 Apr 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ICU PatientsStudies of the same condition, open and under way.
- More trials run by Samsung Medical CenterThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Double blind randomized trial
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 172 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Samsung Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jung Eun Lee, Samsung Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03045692
- Sponsor's protocol ID
- 2016-12-147-003
- Status last verified
- Feb 2017
- First submitted
- 5 Feb 2017
- Last updated
- 8 Feb 2017
- 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 8 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reliable Methods to Assess Kidney Function for Drug Dosage Adjustments in Critically Ill Patients - Comparison of Timed Clearance of Creatinine and Creatinine Based Estimated GFR
- ClinicalTrials.gov ID
- NCT03045692
- Acronym / sponsor ID
- 2016-12-147-003
- Conditions
- ICU Patients
- Keywords
- drug dosing, eGFR, CCr
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 172 participants (estimated)
- Lead sponsor
- Samsung Medical CenterUniversity, hospital or other
- Study start
- 13 Feb 2017 (estimated)
- Primary completion
- 28 Feb 2019 (estimated)
- Study completion
- 30 Apr 2019 (estimated)
- First posted
- 7 Feb 2017 (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.
The aim of the study is to determine if colistin dosage adjustment using 4hr CrCl contribute to better clinical outcomes compared with drug dosage adjustment using eGFR in critical ill patients. In control group, colistin maintenance dosage will be decided using serum creatinine based eGFR (in ml/min). In study group, colistin maintenance dosage will be decided using 4hr CrCl.
Detailed description
- Screening periods (From 'informed consents' to 'randomization')
- Check of inclusion/exclusion criteria ② Measurement of 4hr CrCl \& eGFR in ml/min
- calculation of maintenance dose ③ Baseline characteristics \& laboratory findings ④ Randomization
- Colistin dosage Loading dose : 5 x body weight (not exceeding 300mg) Maintenance dose (after 12 hours from loading dose) : 2.5 x ([1.5 x GFR] + 30) (divided doses every 12hours), GFR in ml/min During the study period, daily morning serm creatinine levels are measured. Whenever serum creatinine concentration changes by more than 10% compared with baseline, 4hr CrCl will be mearued. At the every time of 4hr CrCl measurements, colistin dose wil be modified according to new GFR values (4hr CrCl in study group, eGFR in control group)
- Blood sampling for Colistin trough level measurement Peripheral blood will be sampled twice between 72 hrs and 144 hours after loading dose, just before colistin infusion. The samples were collected in heparined tubes and centrifuged at 4 °C within 1 hr of collection. The resulting plasma was stored at - 70°C . And two values will be averaged out.
- End of randomization (7 days after colistin initiation) ① Nephrotoxicity ② Treatment outcome microbiological outcome: eradication / no eradication clinical outcome: complete response / partial response / treatment failure
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
- Model description
- Double blind randomized trial
| Arm | Type | Receives |
|---|---|---|
| Control group | Active comparator | Diagnostic Test: kidney function assessment by creatinine based eGFRcreatinine based eGFR (which is not revised value with standardized body surface area, that is, 1.73m2) are used to decide colistin maintenance dosage. |
| Study group | Experimental | Diagnostic Test: kidney function assessment by 4 hour creatinine clearance4 hour creatinine clearance is used to decide colistin maintenance dosage. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients aged over 18
- Patients in intensive care unit received colistin for the microbiologically documented cases associated with carbapenem-resistant gram negative bacilli.
Key exclusion criteria (5 listed)
- Patients who received colistin empirically.
- Patients who received renal replacement therapy due to acute kidney injury or end-stage renal disease
- Patients whose urine output was less than 0.5cc/kg/hr for 6 hrs
- Patients who underwent hematopoietic stem cell transplantation
- Patients who disagree with this study.
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 |
|---|---|---|
| kidney function assessment by 4 hour creatinine clearance4 hour creatinine clearance is used to decide colistin maintenance dosage. | Diagnostic test | Study group |
| kidney function assessment by creatinine based eGFRcreatinine based eGFR (which is not revised value with standardized body surface area, that is, 1.73m2) are used to decide colistin maintenance dosage. | Diagnostic test | Control group |
Primary outcome
composite outcome (combination of nephrotoxicity or treatment failure)
Time frame: 7 days after colistin initiation
Nephrotoxicity means development of AKI (according to RIFLE criterior) Treatment failure menas clinically 'no response'
5 secondary outcomes
colistin trough level, renal clearance of colistin
Time frame: 7 days after colistin initiation
ICU stay duration
Time frame: till discharge (Max. 3 months)
Total duration of colistin treatment
Time frame: till discharge (Max. 3 months)
Need for renal replacement therapy
Time frame: 7 days after colistin initiation
In-ICU mortality (infection-attributed mortality)
Time frame: till discharge (Max. 3 months)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Feb 2017.
- Individual participant dataSharing planned: No
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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.
Questions about this trial
What is this clinical trial studying?
A study testing kidney function assessment by 4 hour creatinine clearance and kidney function assessment by creatinine based eGFR in people with ICU Patients, run by Samsung Medical Center.
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 2 inclusion and 5 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 8 Feb 2017. 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 Jung Eun Lee, MD,PhD (82-2-3410-6549, jungeun34.lee@samsung.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
composite outcome (combination of nephrotoxicity or treatment failure) (time frame: 7 days after colistin initiation). 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 8 Feb 2017.