NCT04239937

Brief Summary

An observational study on the insulin resistance in sepsis and septic shock patients.

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
50

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Feb 2020

Shorter than P25 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

First Submitted

Initial submission to the registry

January 21, 2020

Completed
6 days until next milestone

First Posted

Study publicly available on registry

January 27, 2020

Completed
22 days until next milestone

Study Start

First participant enrolled

February 18, 2020

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 27, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 27, 2020

Completed
Last Updated

August 14, 2020

Status Verified

August 1, 2020

Enrollment Period

6 months

First QC Date

January 21, 2020

Last Update Submit

August 13, 2020

Conditions

Septic ShockSepsisInsulin Resistance

Outcome Measures

Primary Outcomes (1)

  • C-peptide

    Changes in C-peptide over time

    28 days

Secondary Outcomes (3)

  • Blood glucose level

    28 days

  • Infection level and C-peptide concentration

    28 days

  • Correlation between infection rate and insulin resistance.

    28 days

Eligibility Criteria

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

Sepsis or septic shock patients.

You may qualify if:

  • Patients with sepsis or septic shock who are admitted to the emergency ward and subsequently transferred to an intensive, intermediate or medical ward at Slagelse Hospital. Patients are diagnosed with sepsis or septic shock based on screening using Sequential (sepsis-related) Organ Failure Assessment (SOFA) or Quick SOFA (qSOFA).
  • Patients must be of legal age.

You may not qualify if:

  • Patients with diabetes (T1DM or T2DM)
  • Patients with terminal cancer
  • Patients who are already participating in a trial
  • Patients who do not understand and speak danish
  • Patients who are demented
  • Postoperative patients \<1 month after surgery
  • Patients who are going through dialysis

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Slagelse Hospital

Slagelse, 4200, Denmark

RECRUITING

MeSH Terms

Conditions

Shock, SepticSepsisInsulin Resistance

Condition Hierarchy (Ancestors)

InfectionsSystemic Inflammatory Response SyndromeInflammationPathologic ProcessesPathological Conditions, Signs and SymptomsShockHyperinsulinismGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Central Study Contacts

Sarah Duncan

CONTACT

0045 61705065duncans@duncans.dk

Peter Gæde

CONTACT

phgo@regionsjaelland.dk

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 21, 2020

First Posted

January 27, 2020

Study Start

February 18, 2020

Primary Completion

August 27, 2020

Study Completion

August 27, 2020

Last Updated

August 14, 2020

Record last verified: 2020-08

Locations

DK(1)