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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05681052
Other study ID # University of Erzincan
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date October 1, 2022
Est. completion date January 21, 2023

Study information

Verified date January 2023
Source Erzincan University
Contact NURCAN KUTLUER KARACA, Asistant Profesor
Phone +905386961814
Email nurcankutluer@yahoo.com
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


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).


Recruitment information / eligibility

Status Recruiting
Enrollment 62
Est. completion date January 21, 2023
Est. primary completion date January 21, 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Locations

Country Name City State
Turkey Nurcan Kutluer Karaca Erzi?ncan

Sponsors (1)

Lead Sponsor Collaborator
Erzincan University

Country where clinical trial is conducted

Turkey, 

Outcome

Type Measure Description Time frame Safety issue
Primary Difference in mottling incidence according to ScvO2 level during a septic shock. at 0th hour, admission; at 6th hour after initial treatment
Primary 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
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