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Acute Kidney Outreach to Reduce Deterioration and Death (AKORDD) (AKORDD)

23. februar 2018 opdateret af: Heart of England NHS Trust

Acute Kidney Outreach to Reduce Deterioration and Death (AKORDD) - A Pilot Study to Look at Enhancing Patient Care, Improving Patient Outcomes and Reducing NHS Costs

The study pilots an outreach service for Acute kidney injury (AKI) patients, based on electronic alerts. Using the alerts we will contact the primary clinician caring for the patient with AKI in the Intervention group. The study has a control group of patients receiving good standard care, but without Outreach. The aim is to reduce morbidity and mortality in the syndrome, and also to reduce healthcare costs.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

Lay summary:

About one in six hospital inpatients suffer Acute Kidney Injury (AKI), also called acute renal failure. About a third of patients with AKI die. The large majority of patients with AKI are managed by doctors who are not kidney experts. Effective AKI advice and treatments are available but not currently integrated into routine care. A recent National review of the care of patients who died from AKI showed poor management of many patients. Early diagnosis of AKI can avoid complications, dialysis (which affects the quality of life of patients, and is costly) or death. AKI is diagnosed by a change in a blood test. We have developed computer software to diagnose AKI earlier. It sends a warning or 'Alert' about the test to our team of kidney experts. We will further develop the settings of the Alert system. It needs to send an Alert for the right patients. We will also study the best way to make clinicians pay attention to their patients who are developing AKI. When our expert Outreach team receive an Alert, they will call the doctor or nurse looking after the patient with AKI. We will advise on the best treatment for that patient, to reduce their risk of death, dialysis and other complications. We will do a pilot study in one large hospital, to further develop the system, and check it reduces the risk of death or complications from AKI. We will use this work to develop a larger trial of this new system of care for patients with AKI in different hospitals. This will convince the wider NHS of the need to change, and show how to prevent or reduce AKI. Ultimately we aim to improve patients' lives by reducing avoidable death and illness from AKI , and also save the NHS money.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

1865

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Det Forenede Kongerige
    • Midlands
      • Birmingham, Midlands, Det Forenede Kongerige, B9 5SS
        • Heart of England hospital NHS trust

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion Criteria:

  • adult patients with an Alert for AKI issued in accordance with the national algorithm for AKI alerts (NHS England)
  • AKI stage 2 or 3 (this criterion is under review during the preparatory phase of the study)

Exclusion Criteria:

  • patients already on dialysis for AKI at the time of alert
  • patients with End stage renal disease
  • patients <18 years of age
  • patients with no evidence of AKI on review of the automated Alert
  • patients dissenting from participation according to the Ethics application

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Sundhedstjenesteforskning
  • Tildeling: Ikke-randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: After study Intervention arm Heartlands

The trial has 4 arms in a Before and After design:

Arm 3. After/Heartlands area patients receiving the experimental intervention

Patients who have AKI and are either inpatients in the Intervention hospital or living within the surrounding catchment area are eligible. The intervention will be in the form of a telephone call to the primary clinician or visit to the patient. The intervention will include:

Rapid diagnosis of AKI cause; Rapid treatment of AKI cause; Stopping 'nephrotoxic' drugs; Early nephrology followup for stage 3 AKI survivors; and preventing recurrent AKI.
Andet: Rapid diagnosis of AKI cause

The Outreach team will advise on an evidence-based package of care:

1) Rapidly establish a credible diagnosis of the cause of AKI including:

  1. Improved assessment of volume status
  2. Standardised use of urine dipstick .
  3. Appropriate sepsis investigations.
  4. Urgent ultrasound with suspected obstruction.
Andet: Rapid treatment of AKI cause
Rapid, limited treatment of hypovolaemia, with avoidance of iatrogenic fluid overload, recently recognised as a significant cause of mortality in AKI. Rapid sepsis therapy. Urgent relief of urinary tract obstruction.
Andet: Stopping 'nephrotoxic' drugs
Cessation of all potentially nephrotoxic drugs.
Andre navne:
  • Avoidance of iatrogenic causes of AKI
Andet: Early nephrology followup for stage 3 AKI
A rapid followup at discharge in an AKI clinic for survivors of stage 3 AKI, within 7 days of discharge for those in hospital, or within 7 days of the Alert for those not admitted to hospital.
Andet: Preventing recurrent AKI
Patients with AKI in the Intervention arm will receive information on preventing AKI during the study.
Andre navne:
  • Patient information to reduce recurrent AKI
Andet: Good standard care
Good standard care will be provided for all patients in non Experimental arms; clinicians will continue to be able to rapidly refer patients for Nephrology advice or review; online guidance will be available for all clinicians and noted in the alerts for all cases of AKI.
Aktiv komparator: After study Control arm Good Hope

The trial has 4 arms in a Before and After design:

Arm 4. After/Good Hope area patients observed whilst receiving active comparator

Patients who have AKI, as shown by having an Alert for such, and are either inpatients in Good Hope Hospital or living within the surrounding catchment area. These patients will receive good standard care (active comparator), but none of the interventions listed for the Intervention group.
Andet: Good standard care
Good standard care will be provided for all patients in non Experimental arms; clinicians will continue to be able to rapidly refer patients for Nephrology advice or review; online guidance will be available for all clinicians and noted in the alerts for all cases of AKI.
Aktiv komparator: Before study Heartlands area

The trial has 4 arms in a Before and After design:

Arm 1. Before/Heartlands area patients observed whilst receiving active comparator

Patients who have AKI, as shown by having an Alert for such, and are either inpatients in Heartlands Hospital or living within the surrounding catchment area. These patients will receive good standard care (active comparator), but none of the interventions listed for the Intervention group.
Andet: Good standard care
Good standard care will be provided for all patients in non Experimental arms; clinicians will continue to be able to rapidly refer patients for Nephrology advice or review; online guidance will be available for all clinicians and noted in the alerts for all cases of AKI.
Aktiv komparator: Before study Good Hope area

The trial has 4 arms in a Before and After design:

Arm 2. Before/Good Hope area patients observed whilst receiving active comparator

Patients who have AKI, as shown by having an Alert for such, and are either inpatients in Good Hope Hospital or living within the surrounding catchment area. These patients will receive good standard care (active comparator), but none of the interventions listed for the Intervention group.
Andet: Good standard care
Good standard care will be provided for all patients in non Experimental arms; clinicians will continue to be able to rapidly refer patients for Nephrology advice or review; online guidance will be available for all clinicians and noted in the alerts for all cases of AKI.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Composite measure of participants not alive, need for dialysis, or progression of AKI stage
Tidsramme: within 30 days
Combined endpoint
within 30 days

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Heart of England NHS Trust

Samarbejdspartnere

University of Warwick
University of Birmingham

Efterforskere

  • Ledende efterforsker: Mark Thomas, FRCP, Heart of England NHS Trust

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart

1. oktober 2014

Primær færdiggørelse (Faktiske)

31. maj 2017

Studieafslutning (Faktiske)

31. maj 2017

Datoer for studieregistrering

Først indsendt

20. marts 2015

Først indsendt, der opfyldte QC-kriterier

24. marts 2015

Først opslået (Skøn)

25. marts 2015

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

26. februar 2018

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

23. februar 2018

Sidst verificeret

1. februar 2018

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • PB-PG-1111-26038

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

Ja

IPD-planbeskrivelse

Contact the Chief Investigator mark.thomas@heartofengland.nhs.uk

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Kliniske forsøg med Akut nyreskade

Kliniske forsøg med Rapid diagnosis of AKI cause

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