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Serial Vasopressin and Copeptin Levels in Children With Sepsis and Septic Shock (VaCoSS)

7. september 2015 opdateret af: Jan Hau Lee

Patients with severe infection can develop very low blood pressure. There are many mechanisms leading to this, and one of them appears to involve a hormone called vasopressin. In children as compared to adults, the mechanism and response to low blood pressure are different for reasons that are not clear. One possibility is the difference in the production and/or response to vasopressin. Vasopressin has become part of the treatment of children with low blood pressure in the setting of severe infection, when other treatment has failed, but its use is on the basis of animal and adult studies. The exact timing and dose is uncertain.

In this research study, the patients will receive standard treatment for sepsis and septic shock, and the investigators will measure the blood levels of vasopressin and a related compound called copeptin (both are required to understand the mechanism of control involved). Blood will need to be taken from patients without any sepsis so as to be able to compare the values in health and in sickness. The patient groups the investigators have chosen for this are those children who will have blood taken anyway as part of their routine care. The aim of this study is to develop an understanding of the body's hormonal response (with respect to vasopressin) to severe infection in children. The long-term aim is to improve the care of critically ill children with severe infection by using the most appropriate dose of vasopressin at the most appropriate time.

Studieoversigt

Status

Afsluttet

Betingelser

Undersøgelsestype

Observationel

Tilmelding (Faktiske)

136

Kontakter og lokationer

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

Studiesteder

      • Singapore, Singapore, 229899
        • KK Women's and Children's Hospital

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

1 dag til 16 år (Barn)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Prøveudtagningsmetode

Ikke-sandsynlighedsprøve

Studiebefolkning

Children between one day of age and sixteen years old.

Beskrivelse

Inclusion Criteria:

Control Group:

  • Neonates admitted for neonatal jaundice requiring phototherapy
  • Previously well patients admitted for elective gastrointestinal endoscopy, patients admitted for non-specific abdominal pain and
  • Pre-operative patients for circumcision, inguinal hernias and chronic orthopaedic conditions

Study Group:

  • The investigators will also enroll children with sepsis and septic shock
  • Sepsis will be defined as proposed by the International pediatric sepsis consensus conference.
  • Children will be recruited into the septic shock group if they have sepsis and features of cardiovascular organ dysfunction as defined by the same consensus conference.

Exclusion Criteria:

  • Neonates weighing less than 2.5 kg
  • Neonates less than 36 weeks gestation
  • Children more than 16 years of age
  • Patients with a history of congenital heart disease
  • Patients with chronic renal impairment
  • Patients with chronic liver impairment
  • Patients on active chemotherapy
  • Patients on chronic mineralocorticoids or glucocorticoids therapy
  • Patients on long-term diuretic therapy
  • Patients with central nervous system tumours
  • Patients with developmental delay

Studieplan

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

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

Kohorter og interventioner

Gruppe / kohorte
1
Kontrolelementer
2
Sepsis
3
Septic Shock

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Tidsramme
Vasopressin and copeptin levels
Tidsramme: First 5 days of admission
First 5 days of admission

Samarbejdspartnere og efterforskere

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

Sponsor

Efterforskere

  • Ledende efterforsker: Jan Hau Lee, MRCPCH(UK), KK Women's and Children's Hospital

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. august 2008

Primær færdiggørelse (Faktiske)

1. december 2011

Studieafslutning (Faktiske)

1. december 2011

Datoer for studieregistrering

Først indsendt

12. juni 2008

Først indsendt, der opfyldte QC-kriterier

13. juni 2008

Først opslået (Skøn)

16. juni 2008

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

9. september 2015

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

7. september 2015

Sidst verificeret

1. september 2015

Mere information

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 Sepsis

3
Abonner