Trial · NCT04493151
Imipenem/Cilastatin/Relebactam PK in ECMO
NCT04493151, Phase 1, Completed, Joseph L. Kuti, PharmD; results first posted 2024-08-07
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Imipenem/Cilastatin/Relebactam PK in ECMO. Trials, record NCT04493151. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04493151
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Imipenem/Cilastatin/Relebactam PK in ECMO
- NCT number
- NCT04493151
- Status
- Completed
- Phases
- Phase 1
- Enrollment
- 8 participants, actual
- Lead sponsor
- Joseph L. Kuti, PharmD
- Conditions
- Sepsis
- Interventions
- Imipenem, Cilastatin and Relebactam
- First posted
- 2020-07-30
- Last updated
- 2024-08-07
- Results first posted
- 2024-08-07
- Limitations and caveats
A study limitation is the protocol defined exclusion of patients on concomitant continuous renal replacement therapy (CRRT), which is common in patients receiving ECMO (extracorporeal membrane oxygenation). Dosing modifications may be necessary in patients receiving both CRRT and ECMO.
Source ClinicalTrials.gov
Registered outcomes4
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Imipenem Clearance | 6 hours (samples collected before the first imipenem/cilastatin/relebactam dose (i.e., blank), and at 0.5 and 6 hours following the first dose, and then at 0, 0.5, 0.75, 1, 2, 4, 5, and 6 hours after the start of the final dose). | The clearance in liters/hour of imipenem from the plasma of critically ill patients receiving ECMO. |
| Primary | Relebactam Clearance | 6 hours (samples collected before the first imipenem/cilastatin/relebactam dose (i.e., blank), and at 0.5 and 6 hours following the first dose, and then at 0, 0.5, 0.75, 1, 2, 4, 5, and 6 hours after the start of the final dose). | The clearance in liters/hour of relebactam from the plasma of critically ill patients receiving ECMO. |
| Secondary | Imipenem Area Under the Curve (AUC) | 6 hours (samples collected before the first imipenem/cilastatin/relebactam dose (i.e., blank), and at 0.5 and 6 hours following the first dose, and then at 0, 0.5, 0.75, 1, 2, 4, 5, and 6 hours after the start of the final dose). | The AUC in milligram\*hour/liter of imipenem calculated from concentrations collected between zero and 6 hours at steady-state |
| Secondary | Relebactam Area Under the Curve (AUC) | 6 hours (samples collected before the first imipenem/cilastatin/relebactam dose (i.e., blank), and at 0.5 and 6 hours following the first dose, and then at 0, 0.5, 0.75, 1, 2, 4, 5, and 6 hours after the start of the final dose). | The AUC in milligram\*hour/liter of relebactam calculated from concentrations collected between zero and 6 hours at steady-state |
Source ClinicalTrials.gov
Outcomes4
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Imipenem Clearance | 6 hours (samples collected before the first imipenem/cilastatin/relebactam dose (i.e., blank), and at 0.5 and 6 hours following the first dose, and then at 0, 0.5, 0.75, 1, 2, 4, 5, and 6 hours after the start of the final dose). | Liters per hour | MEAN | |
| PRIMARY | Relebactam Clearance | 6 hours (samples collected before the first imipenem/cilastatin/relebactam dose (i.e., blank), and at 0.5 and 6 hours following the first dose, and then at 0, 0.5, 0.75, 1, 2, 4, 5, and 6 hours after the start of the final dose). | Liters per hour | MEAN | |
| SECONDARY | Imipenem Area Under the Curve (AUC) | 6 hours (samples collected before the first imipenem/cilastatin/relebactam dose (i.e., blank), and at 0.5 and 6 hours following the first dose, and then at 0, 0.5, 0.75, 1, 2, 4, 5, and 6 hours after the start of the final dose). | mg*h/L | MEAN | |
| SECONDARY | Relebactam Area Under the Curve (AUC) | 6 hours (samples collected before the first imipenem/cilastatin/relebactam dose (i.e., blank), and at 0.5 and 6 hours following the first dose, and then at 0, 0.5, 0.75, 1, 2, 4, 5, and 6 hours after the start of the final dose). | mg*h/L | MEAN |
Source ClinicalTrials.gov
Results by group4
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Imipenem Clearance | Imipenem-Cilastatin-Relebactam | 15.21 | Standard Deviation 6.52 | Liters per hour | |
| Relebactam Clearance | Imipenem-Cilastatin-Relebactam | 6.95 | Standard Deviation 1.34 | Liters per hour | |
| Imipenem Area Under the Curve (AUC) | Imipenem-Cilastatin-Relebactam | 36.9 | Standard Deviation 13.3 | mg*h/L | |
| Relebactam Area Under the Curve (AUC) | Imipenem-Cilastatin-Relebactam | 45.3 | Standard Deviation 33.2 | mg*h/L |
Source ClinicalTrials.gov
Participant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Imipenem-Cilastatin-Relebactam | 8 | |
| Overall Study | COMPLETED | Imipenem-Cilastatin-Relebactam | 7 | |
| Overall Study | NOT COMPLETED | Imipenem-Cilastatin-Relebactam | 1 |
Source ClinicalTrials.gov
Adverse events4
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Alkaline Phosphate Increase | Hepatobiliary disorders | Imipenem-Cilastatin-Relebactam | 1 | 8 | 1 |
| other | C. difficile Diarrhea | Gastrointestinal disorders | Imipenem-Cilastatin-Relebactam | 1 | 8 | 1 |
| other | Increasing Leukocytosis | Infections and infestations | Imipenem-Cilastatin-Relebactam | 2 | 8 | |
| other | Aspartate Aminotransferase Increase | Hepatobiliary disorders | Imipenem-Cilastatin-Relebactam | 1 | 8 | 1 |
Source ClinicalTrials.gov
Adverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Imipenem-Cilastatin-Relebactam | 0 | 8 |
| Total, other adverse events | Imipenem-Cilastatin-Relebactam | 3 | 8 |
| Total, serious adverse events | Imipenem-Cilastatin-Relebactam | 0 | 8 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT04493151
GET https://conductscience.org/api/trials/v1/NCT04493151/registered