Effects of Continuous Haemofiltration vs Intermittent Haemodialysis on Microcirculatory Parameters in Septic Shock
10. november 2016 opdateret af: 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
Studieoversigt
Detaljeret 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.
Undersøgelsestype
Interventionel
Tilmelding (Forventet)
100
Fase
- Ikke anvendelig
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
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Tunis, Tunesien, 1008
- Rekruttering
- Military Hopital of Tunis
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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
16 år til 90 år (Barn, Voksen, Ældre voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Alle
Beskrivelse
Inclusion Criteria:
- septic shock
Exclusion Criteria:
-
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Screening
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
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Eksperimentel: 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.
|
|
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.
|
Hvad måler undersøgelsen?
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
|
|
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
|
at baseline, 6, 12,18, 24, 30, 36, 42 and 48 hours after initiation of renal replacement
|
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
|
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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Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
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. januar 2016
Primær færdiggørelse (Forventet)
1. december 2018
Studieafslutning (Forventet)
1. december 2018
Datoer for studieregistrering
Først indsendt
4. november 2016
Først indsendt, der opfyldte QC-kriterier
10. november 2016
Først opslået (Skøn)
11. november 2016
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
11. november 2016
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
10. november 2016
Sidst verificeret
1. november 2016
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- CVVHFmicro
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