Microcirculatory Guided Goal Directed Fluid Therapy in Septic Shock; a Feasibility Study

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-02-05

Study Completion Date

2020-10-01

Brief Summary

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Prospective single centre study to assess the feasibility of fluid resuscitation guided by macrocirculatory and microcirculation parameters in patients in the early stages of septic shock. The investigators will utilise a novel point of care tool to assess microcirculatory sublingual perfusion in patients with septic shock. This, in combination with conventional haemodynamic monitoring will determine the timing and volume of resuscitative fluid administration. The feasibility of this technique will be determined prior to embarking on a pilot RCT.

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Detailed Description

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Conditions

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Septic Shock

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Feasibility study - single arm

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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GDT feasibility

Patients undergoing microcirculatory goal directed therapy

Group Type EXPERIMENTAL

Intra venous fluid

Intervention Type DRUG

Volume of intra venous fluid administered during GDT protocol

Interventions

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Intra venous fluid

Volume of intra venous fluid administered during GDT protocol

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

Age \> 18 years Within 6 hours of ICU admission Evidence of suspected or confirmed infection Serial Organ Failure Assessment (SOFA) score increase of 2 or more (assuming baseline 0 if no previous measures) Requiring vasopressor therapy to maintain a MAP \> 65mmHg Lactate \> 2 mmol/l despite initial fluid resuscitation Requirement for advanced haemodynamic monitoring (PiCCO system) in the opinion of the attending clinician

Exclusion Criteria

Patients not expected to survive 24 h in whom the intent of treatment is palliative Patients in whom the primary cause of the shock state is cardiogenic

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Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No