Effects of Fluid Resuscitation on Capillary Refilling Time and Organ Functions in Septic Shock

NCT06067516 | Completed

• 1 other identifier: SUKAEK-2023 15/14
• Study Type: observational
• Target: 44
• Locations: 1 country
• Sites: 1

Brief Summary

Since the ultimate target of resuscitation is the microcirculation, normal microcirculatory perfusion appears to be the primary target of ideal resuscitation in septic shock patients. In septic shock patients, microcirculation of the skin may be impaired in the early period due to early sympathetic nervous system activation. Assessment of skin perfusion has also become popular in shock resuscitation because it is easily accessible for clinical assessment. Studies in septic shock patients, showed that capillary refill time correlated with lactate levels measured at 6 hours of resuscitation and was associated with mortality. Additionally, early normalization of capillary refill time has been associated with improved survival in septic shock This study aimed to evaluate the relationship between the change in capillary filling time (microcirculation) and organ perfusion after fluid resuscitation in sepsis patients in intensive care.

Conditions

Sepsis

Keywords

Sepsis; Fluid resuscitation; Capillary refill time; Sequential Organ Failure Assessment

Outcome Measures

Primary Outcomes (1)

• Sequential organ failure assessment score

  The sequential organ failure assessment score, previously known as the sepsis-related organ failure assessment score, is used to track a person's status during the stay in an intensive care unit to determine the extent of a person's organ function or rate of failure. The score is based on six different scores, one each for the respiratory, cardiovascular, hepatic, coagulation, renal and neurological systems. Each organ system is assigned a point value from 0 (normal) to 4 (high degree of dysfunction/failure). Total the Sequential organ failure assessment score ranges from 0 to 24. The Sequential organ failure assessment score is 0 to 6: mortality \< 10%, 7 to 9: mortality 5 - 20%. 10 to 12: mortality 40 - 50%, 13 to 14: mortality 50 - 60%, 15: mortality \> 80%, 15 to 24: mortality \> 90%. The sequential organ failure assessment score changes after fluid loading (normal value sequential organ failure assessment score \< 2).

  up to 24 hours

Secondary Outcomes (2)

• Stroke volume

  up to 24 hours

• Cardiac output

  up to 24 hours

Other Outcomes (1)

• Mortality

  up to 28 days

Study Arms (2)

Group CRT-R

If the CRT measured at T1 decreased equal to or more than 25% compared to the CRT measured at T0

Other: Fluid resuscitations

Group CRT-NR

If the CRT measured at T1 decreased by less than 25% compared to the CRT measured at T0

Other: Fluid resuscitations

Interventions

Fluid resuscitations OTHER

In line with the recommendations in the Surviving Sepsis Guide, fingertip capillary refill time (CRT) will be measured by applying pressure to the index finger for 15 seconds in the T1 time period after 30 mL/kg/3 hours crystalloid infusion.

Group CRT-NR; Group CRT-R

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients admitted to intensive care due to sepsis and septic shock.

You may qualify if:

• Over 18 years old
• Admitted to intensive care with a diagnosis of sepsis or septic shock
• Systolic blood pressure \< 90 mmHg or Mean blood pressure \< 65 mmHg
• Those who need vasopressor medication
• Urine output \< 0.5 ml/kg/h for at least two hours
• Tachycardia (Heart rate \> 100/min)
• Serum Lactate \> 2 mmol/L
• Patients with central venous oxygen saturation (ScvO) \< 70%

You may not qualify if:

• Not approved by the patient or his/her guardian
• Known heart, kidney, liver failure
• The initial cause of shock is neurogenic, cardiogenic or obstructive shock.
• Pregnancy or suspected pregnancy
• Those with amputation or severe organ ischemia
• Those with peripheral artery disease
• Cannot be evaluated optimally with transthoracic echo
• Patients who died in the first 24 hours

Sponsors & Collaborators

• Samsun University: lead

Study Sites (1)

Samsun University

Samsun, Ilkadim, 55090, Turkey (Türkiye)

Location

Related Publications (4)

• Jacquet-Lagreze M, Bouhamri N, Portran P, Schweizer R, Baudin F, Lilot M, Fornier W, Fellahi JL. Capillary refill time variation induced by passive leg raising predicts capillary refill time response to volume expansion. Crit Care. 2019 Aug 16;23(1):281. doi: 10.1186/s13054-019-2560-0.

  PMID: 31420052 BACKGROUND

• Lara B, Enberg L, Ortega M, Leon P, Kripper C, Aguilera P, Kattan E, Castro R, Bakker J, Hernandez G. Capillary refill time during fluid resuscitation in patients with sepsis-related hyperlactatemia at the emergency department is related to mortality. PLoS One. 2017 Nov 27;12(11):e0188548. doi: 10.1371/journal.pone.0188548. eCollection 2017.

  PMID: 29176794 BACKGROUND

• Brunauer A, Kokofer A, Bataar O, Gradwohl-Matis I, Dankl D, Bakker J, Dunser MW. Changes in peripheral perfusion relate to visceral organ perfusion in early septic shock: A pilot study. J Crit Care. 2016 Oct;35:105-9. doi: 10.1016/j.jcrc.2016.05.007. Epub 2016 May 12.

  PMID: 27481743 BACKGROUND

• Monnet X, Shi R, Teboul JL. Prediction of fluid responsiveness. What's new? Ann Intensive Care. 2022 May 28;12(1):46. doi: 10.1186/s13613-022-01022-8.

  PMID: 35633423 BACKGROUND

MeSH Terms

Conditions

Sepsis

Condition Hierarchy (Ancestors)

Infections; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• OZGUR KOMURCU, 1

  Samsun University

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: September 14, 2023
• First Posted: October 5, 2023
• Study Start: October 25, 2023
• Primary Completion: January 5, 2026
• Study Completion: January 5, 2026
• Last Updated: January 7, 2026

Record last verified: 2025-06

Locations

TU (1)