Comparison of Peripheral Perfusion Indicators and Lactate Levels

NCT06727318 | Completed

• 1 other identifier: 2024/208
• Study Type: observational
• Target: 192
• Locations: 1 country
• Sites: 1

Brief Summary

In patients with septic shock undergoing intensive care unit monitoring, routine assessment of arterial and/or venous blood gas is conducted. During the period when arterial and/or venous blood gas is analyzed in this patient cohort, peripheral perfusion indicators will also be examined. Peripheral perfusion indicators will be appraised using capillary refill and mottling score. In patients experiencing septic shock, elevated lactate levels and progressive elevation of lactate levels during monitoring, prolonged capillary refill time exceeding 3 seconds, protracted capillary refill time, mottling development, and escalating mottling score are prognostic indicators of poor outcomes. The objective of this prospective study is to assess the correlation between capillary refill time and mottling score, concurrently evaluated, and serum lactate levels in arterial and/or venous blood gas.

Conditions

Shock, Septic; Hypotensive; Lactate; Sepsis; Lactic Acidosis

Keywords

SEPSİS; SEPTİC SHOCK; CAPİLLER REFİLL TİME; LACTATE İNCRASE; HYPOTENSİVE

Outcome Measures

Primary Outcomes (1)

• USE OF PERİFERAL PERFUSİON ASSESSMENT METHODS

  Arterial and/or venous blood gases measured every 6 hours from the time of diagnosis and concurrent peripheral perfusion findings (capillary refill time, mottling score) will be noted in the first 24 hours. Capillary refill time, mottling score, lactate level measurements will be evaluated separately for septic shock progression and 28-day mortality. Parameters that are significant for septic shock progression in univariate analysis will be evaluated with logistic regression analysis. Then, the correlation between the peripheral perfusion findings and lactate levels will be compared with correlation analysis.

  MAY 2024 SEPTEMBER 2025

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Septic shock patients in the intensive care unit

You may qualify if:

• years of age or older
• Patients in septic shock

You may not qualify if:

• Patients who did not give consent for participation in the study
• Patients under 18 years of age
• Patients with aortic pathology
• Patients with arrhythmias (arrhythmias affecting cardiac index)
• Patients with peripheral arterial disease (Buerger's disease, etc.)
• Patients with a diagnosis of Raynaud's disease
• Patients with chronic liver disease
• Black people
• Pregnancy

Sponsors & Collaborators

• Gulhane Training and Research Hospital: lead

Study Sites (1)

Healty Sciences University Gulhane Training and Research Hospital

Ankara, KEÇİÖREN, 06010, Turkey (Türkiye)

Location

Related Publications (4)

• Stevenson LW, Perloff JK. The limited reliability of physical signs for estimating hemodynamics in chronic heart failure. JAMA. 1989 Feb 10;261(6):884-8.

  PMID: 2913385 RESULT

• Ait-Oufella H, Lemoinne S, Boelle PY, Galbois A, Baudel JL, Lemant J, Joffre J, Margetis D, Guidet B, Maury E, Offenstadt G. Mottling score predicts survival in septic shock. Intensive Care Med. 2011 May;37(5):801-7. doi: 10.1007/s00134-011-2163-y. Epub 2011 Mar 4.

  PMID: 21373821 RESULT

• Cecconi M, De Backer D, Antonelli M, Beale R, Bakker J, Hofer C, Jaeschke R, Mebazaa A, Pinsky MR, Teboul JL, Vincent JL, Rhodes A. Consensus on circulatory shock and hemodynamic monitoring. Task force of the European Society of Intensive Care Medicine. Intensive Care Med. 2014 Dec;40(12):1795-815. doi: 10.1007/s00134-014-3525-z. Epub 2014 Nov 13.

  PMID: 25392034 RESULT

• Singer M, Deutschman CS, Seymour CW, Shankar-Hari M, Annane D, Bauer M, Bellomo R, Bernard GR, Chiche JD, Coopersmith CM, Hotchkiss RS, Levy MM, Marshall JC, Martin GS, Opal SM, Rubenfeld GD, van der Poll T, Vincent JL, Angus DC. The Third International Consensus Definitions for Sepsis and Septic Shock (Sepsis-3). JAMA. 2016 Feb 23;315(8):801-10. doi: 10.1001/jama.2016.0287.

  PMID: 26903338 RESULT

MeSH Terms

Conditions

Sepsis; Shock, Septic; Acidosis, Lactic; Toxemia

Condition Hierarchy (Ancestors)

Infections; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Shock; Acidosis; Acid-Base Imbalance; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: İNTENSİVE CARE SPECİALİST

Study Record Dates

• First Submitted: November 15, 2024
• First Posted: December 10, 2024
• Study Start: May 1, 2024
• Primary Completion: August 18, 2025
• Study Completion: August 18, 2025
• Last Updated: December 5, 2025

Record last verified: 2024-05

Locations

TU (1)