NCT05076864

Brief Summary

Evaluation of the pharmacokinetics of levosimendan and its metabolites in intensive care patients with normal, reduced and dialysis supported renal function.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
12

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jan 2020

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

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

January 1, 2020

Completed
1.7 years until next milestone

First Submitted

Initial submission to the registry

September 30, 2021

Completed
13 days until next milestone

First Posted

Study publicly available on registry

October 13, 2021

Completed
4.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2025

Completed
Last Updated

October 13, 2021

Status Verified

October 1, 2021

Enrollment Period

6 years

First QC Date

September 30, 2021

Last Update Submit

October 12, 2021

Conditions

PharmacokineticsMetabolitesIntensive CareRenal FailureAcute Kidney Injury

Outcome Measures

Primary Outcomes (1)

  • Concentration of levosimendan and OR 1896 1855 in plasma

    Plasma concentrations of levosimendan and its active metabolites afte Levosimendan infusion.

    1-5 days

Interventions

No interventionOTHER

No intervention

Eligibility Criteria

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

Intensive Care Unit patients in whom the treating physician has decided due to clinical indication to administer levosimendan. Dose and length of treatment decided by treating physician. With Group 1: No renal failure or Acute Kidney Injury(AKI)\* stage 1. Group 2: AKI stage 2-3, not receiving renal replacement therapy. Group 3: Receiving continuous renal replacement therapy (CRRT) \*AKI classification system Kidney Disease Improving Global outcomes (KDIGO)

You may qualify if:

  • ° Adult Intensive care patients in whom treating physicians have judged to be in need of Levosimendan treatment.

You may not qualify if:

  • Patient \<18 years of age
  • Pregnancy
  • Patients receiving Intermittent hemodialysis

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Karolinska University Hospital

Stockholm, Sweden

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

Blood (plasma), Urine, Ultrafiltration fluid.

MeSH Terms

Conditions

Renal InsufficiencyAcute Kidney Injury

Condition Hierarchy (Ancestors)

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

Central Study Contacts

Claire Rimes-Stigare, MD, PhD

CONTACT

004651770000claire.rimes-stigare@regionstockholm.se

Susanne Rysz, MD, PhD

CONTACT

004651770000susanne.rysz@regionstockholm.se

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Senior Consultant

Study Record Dates

First Submitted

September 30, 2021

First Posted

October 13, 2021

Study Start

January 1, 2020

Primary Completion

December 31, 2025

Study Completion

December 31, 2025

Last Updated

October 13, 2021

Record last verified: 2021-10

Locations

SE(1)