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Can Respiratory Rate Predict the Risk of Deterioration of Septic Patients

21 november 2018 uppdaterad av: PMD Solutions

The primary objective is to determine if the trend in Respiratory Rate measurements provided by the device under investigation can be used to predict an increase in Sequential/Sepsis-related Organ Failure Assessment (SOFA) score.

The RR trend will be measured as the difference between the RR recorded by the device at a point 15 minutes after commencement of treatment, as per the standard of care for patients suspected of being septic, and a point 3 hours following this.

Studieöversikt

Status

Avslutad

Betingelser

Detaljerad beskrivning

The primary objective is to determine if the trend in Respiratory Rate measurements provided by the device under investigation can be used to predict an increase in Sequential/Sepsis-related Organ Failure Assessment (SOFA) score.

The RR trend will be measured as the difference between the RR recorded by the device at a point 15 minutes after commencement of treatment, as per the standard of care for patients suspected of being septic, and a point 3 hours following this.

Secondary objective The secondary objective is to test if Respiratory Rate can help identify patients at increased risk of 30 day mortality.

The null Hypotheses of the planned comparison is that there is no difference in the RR trend in the 3 hours following commencement of treatment for sepsis in subjects who have an increase in SOFA score by 2 or more points and those who have a change in SOFA score of +1 or less.

The change in SOFA score will be measured at point of commencement of treatment and at 6 hours following commencement of treatment, or nearest available SOFA score determination.

Respiratory Rate captured during admission could have a predictive course for cohort of interest

The time points for reviewing the RR will be as follows:

(i) The last measurement (ii) The trend over 3 hours following commencement of treatment as per the standard of care for patients suspected of being septic.

(iii) The trend over the entire duration of admission

Studietyp

Observationell

Inskrivning (Faktisk)

132

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studieorter

    • South West Jutland
      • Esbjerg, South West Jutland, Danmark, DK-6700
        • Hospital of South West Jutland, Department of Emergency Medicine

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

18 år och äldre (Vuxen, Äldre vuxen)

Tar emot friska volontärer

N/A

Kön som är behöriga för studier

Allt

Testmetod

Icke-sannolikhetsprov

Studera befolkning

For this investigation, the population of interest are patients admitted to the Acute Medical Unit (AMU) with sepsis or that develop sepsis during their admission.

Beskrivning

Inclusion criteria

  • ≥ 18 Years
  • Admitted for a minimum of 12 hours
  • Have been diagnosed with sepsis

Sepsis diagnosis confirmed by documented or suspected infection (ordering of blood culture or other microbiological investigation by the clinician) and ≥1 of the following presenting within the first 4 hours of admission:

  • Fever or hypothermia, Core temperature > 38.3 or < 36 °C
  • Heart rate > 90/min
  • Respiratory rate > 20/min
  • Altered consciousness/mental state, defined as GCS < 15
  • Hyperglycemia, (BS > 6.7 mmol/L non-diabetic)
  • LKC > 12 *10^9 or < 4*10^9,
  • Normal LKC with > 10 % immature cells,
  • CRP > highest normal local lab. Interval
  • Hypotension: Systolic BP <90 mmHg, or drop in systolic BP > 40
  • Hypoxemia: PaO2 < 8.5 Kpa or PaO2/FiO2 < 40 or tissue perfusion: P-lactate > 1.6
  • Creatinine . 177 µmol/L
  • Acute oliguria (Diuresis per hour ,0.5 ml/kg/t or 45 ml/t in 2 hours)
  • Coagulopathy: Spontaneous INR > 1.5, or apt > 60 sec, thrombocytopenia
  • Paralytic ileus (absence of bowel sounds)
  • Hyperbilirubinemia > 34µmol/L
  • Are willing to voluntarily sign a statement of informed consent to participate in this investigation

Exclusion criteria

  • Allergic to medical grade skin adhesive
  • Pregnant women during second and third trimester
  • Continuous long term steroid use. Defined as not using steroids in the 4 weeks previous to enrolment
  • Patients under the influence of substance abuse (drug or alcohol) that may interfere with their ability to cooperate and comply with the investigation procedures
  • Any disorder, including cognitive dysfunction, which would affect the ability to accurately complete questionnaires and freely give full informed consent. This will be determined by the Abbreviated Mental Test Score (AMT) Cannot be followed a second time if admitted again at a later date during the study period

Studieplan

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

Kohorter och interventioner

Grupp / Kohort
Suspicion of Sepsis
Patients who are admitted and are diagnosed with sepsis will be recruited for this investigation.

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
RespiraSense triggered escalation in SOFA score
Tidsram: 15 minutes after commencement of treatment, as per the standard of care for patients suspected of being septic, and a point 3 hours following this.
Escalation of SOFA score by 2 or more points. The primary endpoint will be evaluated with an ANCOVA with escalation of SOFA score by 2 or more points as a factor and mean RR in the first hour of treatment as a covariate.
15 minutes after commencement of treatment, as per the standard of care for patients suspected of being septic, and a point 3 hours following this.

Sekundära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Upward trend in Respiratory Rate as a predictor of 30 day mortality
Tidsram: 30 days after discharge
The secondary endpoint is the 30 day mortality rate after discharge.
30 days after discharge

Andra resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Upward trend in Respiratory Rate as a predictor of 30 day readmission.
Tidsram: 30 days after discharge
The secondary endpoint is the 30 day readmission rate after discharge.
30 days after discharge

Samarbetspartners och utredare

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Sponsor

Samarbetspartners

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart (Faktisk)

23 mars 2017

Primärt slutförande (Faktisk)

9 september 2017

Avslutad studie (Faktisk)

21 november 2017

Studieregistreringsdatum

Först inskickad

20 november 2018

Först inskickad som uppfyllde QC-kriterierna

21 november 2018

Första postat (Faktisk)

23 november 2018

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

23 november 2018

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

21 november 2018

Senast verifierad

1 november 2018

Mer information

Termer relaterade till denna studie

Andra studie-ID-nummer

  • PMD-CS-006ii

Plan för individuella deltagardata (IPD)

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OBESLUTSAM

IPD-planbeskrivning

Data can be shared upon request.

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