Effects of Continuous Haemofiltration vs Intermittent Haemodialysis on Microcirculatory Parameters in Septic Shock
10. november 2016 oppdatert av: Hajjej Zied, Military Hospital of Tunis
The aim of the study was to investigate whether CVVH, in comparison to intermittent haemodialysis (IHD), is able to improve regional perfusion in septic shock patients studied by muscle microdialysis
Studieoversikt
Detaljert beskrivelse
A prospective, randomized, clinical study ,including septic shock patients with acute renal failure, aged over 16 years.
Patients were randomized to receive either CVVH or IHD for renal replacement therapy.
Intermittent haemodialysis was carried out during the first 4 h at day 1 and day 2 of the study period.
Systemic haemodynamics and interstitial tissue concentrations of lactate, pyruvate, glucose and glycerol were obtained at baseline, 6, 12,18 and 24 hours after initiation of renal replacement by using muscle microdialysis.
Studietype
Intervensjonell
Registrering (Forventet)
100
Fase
- Ikke aktuelt
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
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Tunis, Tunisia, 1008
- Rekruttering
- Military Hopital of Tunis
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Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
16 år til 90 år (Barn, Voksen, Eldre voksen)
Tar imot friske frivillige
Nei
Kjønn som er kvalifisert for studier
Alle
Beskrivelse
Inclusion Criteria:
- septic shock
Exclusion Criteria:
-
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Screening
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
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Eksperimentell: CVVHF
CVVHF for 48 h interstitial tissue concentrations of lactate, pyruvate, glucose and glycerol were obtained at baseline, 6, 12,18 and 24 hours after initiation of renal replacement by using muscle microdialysis.
|
Systemic haemodynamics and interstitial tissue concentrations of lactate, pyruvate, glucose and glycerol were obtained at baseline, 6, 12,18 and 24 hours after initiation of renal replacement by using muscle microdialysis.
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Aktiv komparator: IHD for 4 hours
Intermittent haemodialysis was carried out during the first 4 h at day 1 and day 2 of the study period. Interstitial tissue concentrations of lactate, pyruvate, glucose and glycerol were obtained at baseline, 6, 12,18 and 24 hours after initiation of renal replacement by using muscle microdialysis. |
Systemic haemodynamics and interstitial tissue concentrations of lactate, pyruvate, glucose and glycerol were obtained at baseline, 6, 12,18 and 24 hours after initiation of renal replacement by using muscle microdialysis.
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tidsramme |
|---|---|
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changes in the concentration of glucose (mmol/l) in the extracellular fluid of the skeletal muscle using a microdialysis probe inserted into the quadriceps femoris muscle.
Tidsramme: at baseline, 6, 12, 18, 24, 30, 36, 42 and 48 hours after initiation of renal replacement
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at baseline, 6, 12, 18, 24, 30, 36, 42 and 48 hours after initiation of renal replacement
|
|
changes in the concentration of lactate (mmol/l) in the extracellular fluid of the skeletal muscle using a microdialysis probe inserted into the quadriceps femoris muscle
Tidsramme: at baseline, 6, 12, 18, 24, 30, 36, 42 and 48 hours after initiation of renal replacement
|
at baseline, 6, 12, 18, 24, 30, 36, 42 and 48 hours after initiation of renal replacement
|
|
changes in the concentration of pyruvate (µmol/l) in the extracellular fluid of the skeletal muscle using a microdialysis probe inserted into the quadriceps femoris muscle
Tidsramme: at baseline, 6, 12, 18, 24, 30, 36, 42 and 48 hours after initiation of renal replacement
|
at baseline, 6, 12, 18, 24, 30, 36, 42 and 48 hours after initiation of renal replacement
|
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changes in the concentration of glycerol (µmol/l) in the extracellular fluid of the skeletal muscle using a microdialysis probe inserted into the quadriceps femoris muscle
Tidsramme: at baseline, 6, 12,18, 24, 30, 36, 42 and 48 hours after initiation of renal replacement
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at baseline, 6, 12,18, 24, 30, 36, 42 and 48 hours after initiation of renal replacement
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Sekundære resultatmål
Resultatmål |
Tidsramme |
|---|---|
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changes in mean arterial blood pressure
Tidsramme: at baseline, 6, 12, 18, 24, 30, 36, 42 and 48 hours after initiation of renal replacement
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at baseline, 6, 12, 18, 24, 30, 36, 42 and 48 hours after initiation of renal replacement
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changes in heart rate
Tidsramme: at baseline, 6, 12, 18, 24, 30, 36, 42 and 48 hours after initiation of renal replacement
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at baseline, 6, 12, 18, 24, 30, 36, 42 and 48 hours after initiation of renal replacement
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changes in vasopressor support doses
Tidsramme: at baseline, 6, 12, 18, 24, 30, 36, 42 and 48 hours after initiation of renal replacement
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at baseline, 6, 12, 18, 24, 30, 36, 42 and 48 hours after initiation of renal replacement
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Samarbeidspartnere og etterforskere
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Sponsor
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart
1. januar 2016
Primær fullføring (Forventet)
1. desember 2018
Studiet fullført (Forventet)
1. desember 2018
Datoer for studieregistrering
Først innsendt
4. november 2016
Først innsendt som oppfylte QC-kriteriene
10. november 2016
Først lagt ut (Anslag)
11. november 2016
Oppdateringer av studieposter
Sist oppdatering lagt ut (Anslag)
11. november 2016
Siste oppdatering sendt inn som oppfylte QC-kriteriene
10. november 2016
Sist bekreftet
1. november 2016
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- CVVHFmicro
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