Capillary Refill Time Response to a Rapid Fluid Challenge in Septic Shock Patients

NCT04693923 | Unknown

• 1 other identifier: 190527001
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

Brief Summary

In septic shock patients, the hemodynamic coherence between systemic, regional and microcirculatory blood flow can be tracked by "capillary refill time (CRT) response to an increase in stroke volume induced by a rapid fluid challenge". A parallel improvement in regional blood flow, microcirculation and hypoperfusion-related parameters should be expected in CRT-responders as reflection of preserved hemodynamic coherence. CRT non-response is associated with a more severe systemic inflammatory state, endothelial and microvascular dysfunction, and a higher adrenergic tone. The objective of this study is to determine if CRT response after a rapid fluid challenge signals a state of hemodynamic coherence as demonstrated by a parallel improvement in regional and microcirculatory blood flow in CRT-responders, and to explore the pathophysiological mechanisms associated to CRT non-response.

Conditions

Septic Shock

Outcome Measures

Primary Outcomes (1)

• Normalization of capillary refill time (CRT)

  CRT-response is defined as normalization of the variable after the fluid challenge (normal value CRT ≤3.0 secs).

  At baseline, and immediately after the single fluid challenge; then at 30 minutes, and 1, 2, 6 and 24h.

Secondary Outcomes (11)

• Procalcitonin

  Baseline, and at 6 and 24h after the single fluid challenge

• IL-6

  Baseline, and at 6 and 24h after the single fluid challenge

• IL-10

  Baseline, and at 6 and 24h after the single fluid challenge

• TNF-alpha

  Baseline, and at 6 and 24h after the single fluid challenge

• Syndecan-1

  Baseline, and at 6 and 24h after the single fluid challenge

Other Outcomes (13)

• Vascular occlusion test assessed by NIRS

  Baseline, at 30 min, and at 1, 6 and 24h after the single fluid challenge

• Vascular occlusion test assessed by Laser-Doppler

  Baseline, at 30 min, and at 1, 6 and 24h after the single fluid challenge

• Test of thermal challenge with Laser-Doppler, assessed by dedicated software

  Baseline, at 30 min, and at 1, 6 and 24h after the single fluid challenge

Study Arms (2)

Group A (rapid fluid challenge)

EXPERIMENTAL

Patients will receive a rapid fluid challenge (4ml/kg of crystalloids in 5 minutes using a syringe of 60 mL and a timer in the multiparameter monitor).

Procedure: Fluid challenge

Group B (standard fluid challenge)

ACTIVE COMPARATOR

Patients will receive a standard fluid challenge (500 ml of crystalloids in 30 minutes).

Procedure: Fluid challenge

Interventions

Fluid challenge PROCEDURE

Fluid challenge according to the assigned group

Group A (rapid fluid challenge); Group B (standard fluid challenge)

Eligibility Criteria

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

You may qualify if:

• Septic shock according to the Sepsis-3 Consensus Conference \[1\], basically septic patients with hypotension requiring norepinephrine (NE) to maintain a MAP of 65 mmHg, and serum lactate levels \> 2 mmol/l after initial fluid resuscitation.
• Less than 24h after fulfilling criteria for septic shock
• Abnormal CRT (\>3 secs)
• Mechanical ventilation
• Sinus rhythm with positive predictors of fluid responsiveness \[4\]
• Continuous CO monitor, arterial line and central venous catheters in place
• Required fluid challenge as decided by the attending physician.

You may not qualify if:

• Pregnancy
• Emergency surgery or dialytic procedure scheduled within the next two hours
• Do-not-resuscitate status
• Active bleeding
• Severe acute respiratory distress syndrome
• Right ventricular failure

Sponsors & Collaborators

• Pontificia Universidad Catolica de Chile: lead
• Fondo Nacional de Desarrollo Científico y Tecnológico, Chile: collaborator

Study Sites (1)

Pontificia Universidad Catolica de Chile

Santiago, Santiago Metropolitan, 7500000, Chile

Location

Related Publications (70)

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MeSH Terms

Conditions

Shock, Septic

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor

Model Details: This is a randomized controlled study in parallel groups.

Study Record Dates

• First Submitted: December 21, 2020
• First Posted: January 5, 2021
• Study Start: February 1, 2021
• Primary Completion: June 1, 2023
• Study Completion: September 1, 2023
• Last Updated: January 5, 2021

Record last verified: 2020-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: 6 months after completing recruitment
• Access Criteria: Formal request from investigators

Locations

CL (1)