NCT03507751

Brief Summary

Assessment of meropenem plasma concentration in critically ill patients who require CRRT (continuous renal replacement therapy). A standard dose of meropenem is administered, i.e. 1 gram every 8 hours.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
19

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Apr 2018

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 2, 2018

Completed
13 days until next milestone

First Submitted

Initial submission to the registry

April 15, 2018

Completed
10 days until next milestone

First Posted

Study publicly available on registry

April 25, 2018

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2018

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

February 2, 2019

Completed
Last Updated

November 28, 2023

Status Verified

November 1, 2023

Enrollment Period

9 months

First QC Date

April 15, 2018

Last Update Submit

November 22, 2023

Conditions

InfectionRenal Failure

Outcome Measures

Primary Outcomes (1)

  • Plasma concentration of meropenem

    3 days

Study Arms (1)

Meropenem

Patients who require meropenem and CRRT during ICU (intensive care unit) stay

Drug: MeropenemDevice: CRRT

Interventions

MeropenemDRUG

1.0 gram of meropenem given intravenously every 8 hours

Meropenem
CRRTDEVICE

Continuous renal replacement therapy for three days

Meropenem

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Severely ill patients treated in ICU

You may qualify if:

  • Patients who require ICU treatment due to severe infection
  • age 18-80 years
  • an eligible consent obtained from the patient or his/her attendant

You may not qualify if:

  • allergy to meropenem
  • lack of consent to participate in the study
  • age of patients below 18 or above 80 years

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Oddział Kliniczny Anestezjologii i Intensywnej Terapii, Wojewódzki Szpital Specjalistyczny w Olsztynie

Olsztyn, 10- 561, Poland

Location

Biospecimen

Retention: SAMPLES WITH DNA

Blood samples for obtaining meropenem concentrations

MeSH Terms

Conditions

InfectionsRenal Insufficiency

Interventions

Meropenem

Condition Hierarchy (Ancestors)

Kidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital Diseases

Intervention Hierarchy (Ancestors)

ThienamycinsCarbapenemsbeta-LactamsLactamsAmidesOrganic ChemicalsHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
M.D., Ph.D.

Study Record Dates

First Submitted

April 15, 2018

First Posted

April 25, 2018

Study Start

April 2, 2018

Primary Completion

December 31, 2018

Study Completion

February 2, 2019

Last Updated

November 28, 2023

Record last verified: 2023-11

Data Sharing

IPD Sharing
Will not share

Locations

PL(1)