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Allostasis and Sedation Practices in the Critically Ill

Observational pilot study evaluating markers of physiological stress response in mechanically ventilated intensive care patients

Status
Completed
Phases
Unknown
Study type
Observational
Source
ANZCTR
Registry ID
ACTRN12616000083493
Acronym
All-SPICE OPS
Enrollment
12
Registered
2016-01-27
Start date
2015-08-13
Completion date
2015-11-30
Last updated
2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

The survival of an organism in the face of internal and external events requires a measured and appropriate stress response. Recent strands of evidence suggest that an abnormal stress response is linked to the likelihood of the development and severity of critical illness and multi-organ failure. The stress response is coordinated by primitive brain structures in response to sensory inputs and comprises a broad range of effects. We hypothesise that the use of sedating medications confuses the normal generation of a stress response. If this is confirmed, this may be a fundamental underlying cause for the abnormal physiology, metabolic disturbances and organ dysfunction observed in critical illness. The current large multi-centre randomised-controlled Sedation Practices in Intensive Care Evaluation III (SPICE-III) study, in offers the opportunity to study two similar groups of patients who may have differing levels of physiological stress as a result of an Early Goal-Directed Sedation (EGDS) strategy as compared to standard care. The proposed observational study, to be conducted at Nambour Hospital, aims to provide the investigators with pilot data to determine the optimum timing of sampling for a stress panel and to conduct a statistical plan for a randomised–controlled sub-study of the larger SPICE-III study.

Interventions

Patients will have blood sampled every twelve hours for 5 days

Sponsors

Sunshine Coast Health and Hospitals District
Lead SponsorHospital

Eligibility

Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

Admitted to the Intensive Care Unit Mechanically Ventilated Likely to be ventilated for >24hrs

Exclusion criteria

- <18yrs - Pregnant - Primary cardiac diagnosis - Ventilated >12hrs - Enrolled in the intervention arm of the SPICE study - Primary brain lesion - Overdose - Burns - MAP <50 despite adequate resuscitation - Fulminant hepatic failure - Full-time residential nursing care - Imminent/inevitable death - Unlikely to survive to 90 days

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026