Mottling Score and Central Venous Oxygen Saturation in Septic Shock Patients

January 11, 2023 updated by: Nurcan Kutluer Karaca, Erzincan University
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.

Study Overview

Status

Recruiting

Conditions

Detailed Description

This study prospectively analyzed the data of patients admitted to our ICU between October 2022 to December 2022. All septic patients in whom the ScvO2 was measured and mottling scores were evaluated were included. This study enrolled patients aged ≥ 18 years in septic shock. Those excluded have peripheral arterial disease, black skin, cutaneous infection of the lower limbs, pregnancy, and relative refusal. The characteristics of patients were recorded at admission (H0), including demographics (age, sex, body mass index (BMI), admission the Acute Physiology and Chronic Health Evaluation (APACHE II) score, Glasgow Coma Scale (GCS) and sequential organ failure assessment (SOFA) score. Variables such as plasma lactate level, daily urine output, plasma creatinine level, the ratio of arterial oxygen pressure related to inspired oxygen fraction (PaO2/FiO2), hemoglobin level, heart rate, mean arterial pressure, pulsatile saturation in oxygen (SpO2) and body temperature were recorded at H0 and 6 hours after initial resuscitation (H6).

Study Type

Observational

Enrollment (Anticipated)

62

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Turkey
      • Erzi̇ncan, Turkey
        • Recruiting
        • Nurcan Kutluer Karaca
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

All patients aged ≥ 18 years in septic shock

Description

Inclusion Criteria:

  • patients aged ≥ 18 years in septic shock.

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Difference in mottling incidence according to ScvO2 level during a septic shock.
Time Frame: at 0th hour, admission; at 6th hour after initial treatment
at 0th hour, admission; at 6th hour after initial treatment
Difference in mottling score according to ScvO2 level during a septic shock.
Time Frame: at 0th hour, admission; at 6th hour after initial treatment
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Erzincan University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 1, 2022

Primary Completion (Anticipated)

January 21, 2023

Study Completion (Anticipated)

January 21, 2023

Study Registration Dates

First Submitted

December 23, 2022

First Submitted That Met QC Criteria

January 10, 2023

First Posted (Actual)

January 11, 2023

Study Record Updates

Last Update Posted (Actual)

January 12, 2023

Last Update Submitted That Met QC Criteria

January 11, 2023

Last Verified

January 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • University of Erzincan

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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