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Intensive Management of Pressure and Volume Expansion in Patients With Subarachnoid Hemorrhage (IMPROVES)

18. juni 2013 opdateret af: Miriam Treggiari, University of Washington
The purpose of our study is to determine how well Triple-H works and how safe it is. The investigators are hoping to determine the effects of starting the therapy early and to explore if hypervolemia and/or hypertension are beneficial, and what the optimal target ranges are.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

Efficacy of Triple-H therapy.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

20

Fase

  • Fase 1

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:

  1. Age more than or equal to 18 years
  2. Aneurysmal SAH of any clinical grade
  3. Head computed tomography demonstrating SAH
  4. Cerebral angiography revealing the presence of cerebral aneurysm(s) in a location that explains the SAH
  5. Treatment of aneurysm with clipping or coiling must be carried out prior to randomization and within 72 hours of bleeding
  6. Signed consent by study participant or applicable legal representative within 72 hours after SAH

Exclusion Criteria:

  1. History of traumatic SAH
  2. Non-aneurysmal SAH as indicated by no demonstrable aneurysm by cerebral angiography
  3. Presence of an unsecured intracranial aneurysm(s) at risk of rupture that in the opinion of the Investigator would compromise the safety of the patient or the quality of the data
  4. Delayed referral with clipping/coiling greater than 72 hours after the initial bleeding
  5. Time of symptom onset cannot be reliably determined
  6. Intracranial hypertension (ICP >25 mm Hg) at the time of screening
  7. History within the past six months and/or physical findings on admission of decompensated congestive heart failure (NYHA functional class III or IV, or objective class C or D)
  8. Acute, evolving or recent myocardial infarction
  9. Cardiac arrhythmia or second and third degree atrio-ventricular block causing hemodynamic instability
  10. Chronic renal failure requiring dialysis
  11. Suspected or confirmed pregnancy
  12. Non English speaking
  13. A condition that would preclude the performance of the neurobehavioral test battery due to a prior diagnosis of Alzheimer's disease, stroke, degenerative condition, cerebral tumor, or mental retardation
  14. Severe terminal disease with life expectancy less than 6 months
  15. Refusal of consent

Studieplan

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

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Forebyggelse
  • Tildeling: Randomiseret
  • Interventionel model: Faktoriel opgave
  • Maskning: Enkelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Aktiv komparator: Normal Fluids & Normal Blood Pressure
Patients are treated with conventional fluid replacement (Normovolemia) and maintenance of blood pressure in a normal range (Conventional Blood Pressure).
Andet: Fluid manipulation
Patients are treated with conventional fluid replacement (Normovolemia) or increased the fluid replacement (Hypervolemia) for 10 days.
Andre navne:
  • Hypervolemia
  • Normovolemia
Andet: Blood Pressure Manipulation
Patients are treated with maintenance of blood pressure in a normal range (Conventional Blood Pressure) or increased the blood pressure (Augmented Blood Pressure) for 10 days.
Andre navne:
  • Conventional Blood Pressure
  • Augmented Blood Pressure
Aktiv komparator: Increased Fluids & Normal Blood Pressure
Patients are treated with fluids to achieve higher volume expansion (Hypervolemia) and maintenance of blood pressure in a normal range (Conventional Blood Pressure)
Andet: Fluid manipulation
Patients are treated with conventional fluid replacement (Normovolemia) or increased the fluid replacement (Hypervolemia) for 10 days.
Andre navne:
  • Hypervolemia
  • Normovolemia
Andet: Blood Pressure Manipulation
Patients are treated with maintenance of blood pressure in a normal range (Conventional Blood Pressure) or increased the blood pressure (Augmented Blood Pressure) for 10 days.
Andre navne:
  • Conventional Blood Pressure
  • Augmented Blood Pressure
Aktiv komparator: Normal Fluids & Higher Blood Pressure
Patients are treated with conventional fluid replacement (Normovolemia) and maintenance of blood pressure in a higher range (Augmented Blood Pressure).
Andet: Fluid manipulation
Patients are treated with conventional fluid replacement (Normovolemia) or increased the fluid replacement (Hypervolemia) for 10 days.
Andre navne:
  • Hypervolemia
  • Normovolemia
Andet: Blood Pressure Manipulation
Patients are treated with maintenance of blood pressure in a normal range (Conventional Blood Pressure) or increased the blood pressure (Augmented Blood Pressure) for 10 days.
Andre navne:
  • Conventional Blood Pressure
  • Augmented Blood Pressure
Aktiv komparator: Increased Fluids & Higher Blood Pressure
Patients are treated with fluids to achieve higher volume expansion (Hypervolemia) and maintenance of blood pressure in a higher range (Augmented Blood Pressure).
Andet: Fluid manipulation
Patients are treated with conventional fluid replacement (Normovolemia) or increased the fluid replacement (Hypervolemia) for 10 days.
Andre navne:
  • Hypervolemia
  • Normovolemia
Andet: Blood Pressure Manipulation
Patients are treated with maintenance of blood pressure in a normal range (Conventional Blood Pressure) or increased the blood pressure (Augmented Blood Pressure) for 10 days.
Andre navne:
  • Conventional Blood Pressure
  • Augmented Blood Pressure

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Our primary endpoint is to determine the feasibility of the pilot study within the ICU setting and collect preliminary estimates for sample size calculations.
Tidsramme: 6 months
1. Estimation of the eligible population once specific study inclusion & exclusion criteria are applied 2. Estimation of enrollment projections, retention, attrition & losses to follow up; 3. Assessment of compliance with protocol instructions; 4. Evaluation of protocol violations; 5. Achievement of pre-determined hemodynamic goals in each study group.
6 months

Samarbejdspartnere og efterforskere

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

Sponsor

University of Washington

Efterforskere

  • Ledende efterforsker: Miriam Treggiari, MD, PhH, MPH, University of Washington

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. april 2010

Primær færdiggørelse (Faktiske)

1. december 2012

Studieafslutning (Faktiske)

1. december 2012

Datoer for studieregistrering

Først indsendt

5. april 2010

Først indsendt, der opfyldte QC-kriterier

10. august 2011

Først opslået (Skøn)

11. august 2011

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

20. juni 2013

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

18. juni 2013

Sidst verificeret

1. juni 2013

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • 37222-A

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 .

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