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Starch or Saline After Cardiac Surgery (SSACS)

13. august 2019 opdateret af: Dave Nagpal, London Health Sciences Centre

Short-term Outcomes of Fluid Replacement and Resuscitation Strategy in the Cardiac Surgery Patient: A Randomized, Controlled Trial

When people undergo major surgery, they require intravenous supplementation of fluids for a number of reasons:

  • to compensate for no oral intake
  • to support blood pressure and organ function during and after surgery
  • to replace lost fluid or blood volume

There are a variety of fluid choices doctors have to provide to patients, and it is still not definitively known whether some fluids are better than others in specific situations. This is a particularly interesting question in patients undergoing heart surgery because of the significant volume of fluids used over the entire course of hospitalization, including before the operation, during the operation, and after the operation.

There has been some scientific evidence that the use of starch-based fluids (synthetic colloids) leads to better oxygen delivery to the organs with a smaller volume of fluid given, providing for better recovery from surgery. However, there has also been some scientific evidence that the use of these fluids can harm kidney function. Importantly, none of these large-scale studies were carried out specifically in patients undergoing heart surgery.

The purpose of this study is to answer the question of whether the use of starch-based fluid in the heart surgery patient makes for a safer and faster recovery, causes kidney dysfunction, or makes no discernable difference.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

69

Fase

  • Ikke anvendelig

Kontakter og lokationer

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

Studiesteder

  • Canada
    • Ontario
      • London, Ontario, Canada, N6A 5A5
        • London Health Sciences Centre

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:

  • patients undergoing elective primary isolated on-pump coronary artery bypass grafting

Exclusion Criteria:

  • pregnant patients
  • patients with an active intra-cranial bleed
  • patients with a history of hypersensitivity to starch solutions
  • patients with Stage 4 or 5 Kidney Disease (estimated glomerular filtration rate < 30 ml / min / 1.73 m2)
  • patients with a significant preoperative metabolic acidosis, defined by a preoperative capillary blood pH less than or equal to 7.2 and a serum bicarbonate less than 15

Studieplan

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

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Firedobbelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Aktiv komparator: Starch group
Patients randomized to the Starch group will receive Voluven (6% Hydroxyethyl Starch 130/0.4) for their intravenous bolus and fluid resuscitation requirements.
Medicin: 6% Hydroxyethyl Starch 130/0.4
Aktiv komparator: Saline group
Patients randomized to the Saline group will receive 0.9% Normal Saline for their intravenous fluid bolus and resuscitation requirements
Medicin: 0.9% Normal Saline

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Tidsramme
Incidence of acute kidney injury as defined by RIFLE criteria
Tidsramme: Short term (in hospital, up to 30 days) and mid-term (2 months)
Short term (in hospital, up to 30 days) and mid-term (2 months)
Maximum postoperative weight gain
Tidsramme: Short-term (in hospital, up to 7 days)
Short-term (in hospital, up to 7 days)

Sekundære resultatmål

Resultatmål
Tidsramme
Operative mortality
Tidsramme: In hospital (up to 30 days)
In hospital (up to 30 days)
Duration of ventilation support requirements
Tidsramme: In hospital (up to 30 days)
In hospital (up to 30 days)
Total chest tube drainage (until removed)
Tidsramme: In hospital (up to 30 days)
In hospital (up to 30 days)
ICU length of stay
Tidsramme: In hospital (up to 30 days)
In hospital (up to 30 days)
Transfusion of blood products
Tidsramme: In hospital (up to 30 days)
In hospital (up to 30 days)
Incidence of atrial fibrillation (necessitating a change in medical management)
Tidsramme: In hospital (up to 30 days)
In hospital (up to 30 days)
Duration of oxygen supplementation
Tidsramme: In hospital (up to 30 days)
In hospital (up to 30 days)
Creatinine, Urea, Cr Clearance as estimated by the MDRD formula
Tidsramme: In hospital at defined timepoints, and at 2 months post hospital discharge
In hospital at defined timepoints, and at 2 months post hospital discharge
Volume of fluid infused
Tidsramme: In hospital (up to 7 days)
In hospital (up to 7 days)
Total hospital length of stay (when ready to leave tertiary hospital setting)
Tidsramme: In hospital
In hospital

Samarbejdspartnere og efterforskere

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

Sponsor

London Health Sciences Centre

Efterforskere

  • Studieleder: Dave Nagpal, MD, LHSC / UWO
  • Ledende efterforsker: Ray Guo, MD, LHSC / UWO
  • Ledende efterforsker: Chris Harle, MD, LHSC / UWO

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 (Faktiske)

1. august 2009

Primær færdiggørelse (Faktiske)

1. juni 2010

Studieafslutning (Faktiske)

1. juni 2012

Datoer for studieregistrering

Først indsendt

20. august 2009

Først indsendt, der opfyldte QC-kriterier

21. august 2009

Først opslået (Skøn)

24. august 2009

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

15. august 2019

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

13. august 2019

Sidst verificeret

1. august 2019

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • LHSC

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 Koronararterie bypass kirurgi

  • IRCCS Policlinico S. Donato
    Rekruttering
    Anomal aorta-oprindelse af koronararterie (AAOCA)
    Anomalous aorta origin of the coronary artery (AAOCA)
    Italien
  • IRCCS Policlinico S. Donato
    University of Pavia; University of Naples; The Mediterranean Institute for...
    Rekruttering
    Fremskynd diagnosticering og evaluering af anomaløs kranspulsåre fra aorta (SMART)
    Myokardieiskæmi | Pludselig hjertedød | Anomal koronararterieoprindelse | Anomal koronararterie, der opstår fra den modsatte sinus | Anomal koronararterie med aorta-oprindelse og forløb mellem de store arterier | Anomalous aorta origin of the coronary artery (AAOCA) | Myokardieiskæmi, Angina Pectoris og andre forhold
    Italien

Kliniske forsøg med 6% Hydroxyethyl Starch 130/0.4

Søg i lignende forsøg

Sponsorer og samarbejdspartnere

Medicinske tilstande

Narkotikainterventioner

CROs by country

CROs in Vietnam

Betingelser

Sjældne sygdomme

Narkotikainterventioner

Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

Abonner