NCT05681052

Brief Summary

Mottling score and central venous oxygen saturation are described as a clinical evaluation of tissue perfusion. This study describes mottling incidence and mottling score in septic shock patients according to central venous oxygen saturation.

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
62

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Oct 2022

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

Study Start

First participant enrolled

October 1, 2022

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

December 23, 2022

Completed
19 days until next milestone

First Posted

Study publicly available on registry

January 11, 2023

Completed
10 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 21, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 21, 2023

Completed
Last Updated

January 12, 2023

Status Verified

January 1, 2023

Enrollment Period

4 months

First QC Date

December 23, 2022

Last Update Submit

January 11, 2023

Conditions

Outcome Measures

Primary Outcomes (2)

  • Difference in mottling incidence according to ScvO2 level during a septic shock.

    at 0th hour, admission; at 6th hour after initial treatment

  • Difference in mottling score according to ScvO2 level during a septic shock.

    0 score is minimum level, meaning no mottling, meaning better outcome 5 score is maximum level, meaning more mottling, meaning worse outcome

    at 0th hour, admission; at 6th hour after initial treatment

Eligibility Criteria

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

All patients aged ≥ 18 years in septic shock

You may qualify if:

  • patients aged ≥ 18 years in septic shock.

You may not qualify if:

  • patients having the peripheral arterial disease
  • black skin,
  • cutaneous infection of the lower limbs
  • pregnancy
  • relative refusal

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Nurcan Kutluer Karaca

Erzincan, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Shock, Septic

Condition Hierarchy (Ancestors)

SepsisInfectionsSystemic Inflammatory Response SyndromeInflammationPathologic ProcessesPathological Conditions, Signs and SymptomsShock

Central Study Contacts

NURCAN KUTLUER KARACA, Asistant Profesor

CONTACT

Study Design

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

Study Record Dates

First Submitted

December 23, 2022

First Posted

January 11, 2023

Study Start

October 1, 2022

Primary Completion

January 21, 2023

Study Completion

January 21, 2023

Last Updated

January 12, 2023

Record last verified: 2023-01

Locations