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Study of Nutrition in Acute Pancreatitis (SNAP)

26. januar 2016 opdateret af: David Whitcomb, University of Pittsburgh

Feeding and Pancreatic Rest in Acute Pancreatitis

We will compare the two types of enteral (intestinal) nutrition in regard to patients with severe acute pancreatitis in our institution and also in 8 others in the United States.

Studieoversigt

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

23

Fase

  • Ikke anvendelig

Kontakter og lokationer

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

Studiesteder

    • Alabama
      • Birmingham, Alabama, Forenede Stater, 35294
        • University of Alabama
    • Florida
      • Gainesville, Florida, Forenede Stater, 32610
        • University of Florida College of Medicine
    • Indiana
      • Indianapolis, Indiana, Forenede Stater, 46202
        • Indiana University
    • Pennsylvania
      • Pittsburgh, Pennsylvania, Forenede Stater, 15261
        • University of Pittsburgh Medical Center

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. Patients over the age of 18yr
  2. The typical history of abdominal pain for over 24h with raised (>3-fold) serum pancreatic enzymes on admission
  3. Severe pancreatitis, as defined by: the Atlanta classification of severe disease (60), but with important modifications to sharpen the definition of severity, to include one or more of the following:

    1. The presence of organ failure (MOF) resistant to early aggressive IV fluid resuscitation as defined by a Marshall score of ≥2 in any one organ (for calculation, see Appendix (61)), excluding the liver component as the abnormality may be due to gall stones rather than the systemic inflammatory response (17)
    2. Pancreatic necrosis >30% on CT scan or a modified CT severity index (CTSI: see Appendix (62)) of ≥8
    3. APACHE score ≥ 8 (for calculation, see Appendix (63))
    4. Ranson's criteria ≥3 (for calculation, see Appendix (64))

Exclusion Criteria:

  1. Inability to absorb enteral nutrients resulting in chronic intestinal failure and need for IV feeding, such as short bowel, malabsorption disorders such as celiac or intestinal proliferative disorders, chronic obstruction and pseudo-obstruction.
  2. Time elapse since commencement of acute pancreatitis symptoms >10 days. In order to take advantage of the 'window of opportunity' to prevent the progression of 'transient' MOF to 'permanent' MOF, patients should be started on enteral feeding as soon as possible. However, in practice many patients present initially with mild disease which progresses to severe necrosis at the end of the first week, and these patients need nutritional support for long periods of time. Consequently, this is an important group to include in this investigation. Post hoc analysis will be performed to see whether they behave differently to patients fed earlier in their disease
  3. Any form of artificial feeding since commencement of acute pancreatitis symptoms
  4. Patients with chronic pancreatitis and pancreatic insufficiency requiring pancreatic enzyme supplements, based on clinical history and specific investigations such as by ERCP, MRP, or CT scanning.
  5. Pre-existing chronic renal insufficiency requiring hemodialysis or peritoneal dialysis, as this will make assessment of severity difficult
  6. Pre-existing end-stage liver disease with ascites, coagulopathy and encephalopathy, supported by biopsy, and/or radiological imaging and endoscopy (portal hypertension, varices and gastropathy), as this will make assessment of severity difficult
  7. Chronic immunodeficiency states such as AIDS defined by CD-4 count < 50, and immunoglobulin deficiencies as it may independently affect feeding tolerance and infection risk
  8. Pancreatic cancer proven by biopsy, and any other form of cancer with life-expectancy <6 months.
  9. Current somatostatin or corticosteroid therapy as these drugs will impair intestinal, metabolic, and immune function, and therefore affect absorption and infection risk.
  10. Contraindication to using the nose for enteral tube insertion
  11. Severe traumatic brain injury with ICP>20mmHg despite treatment
  12. Previous completion or withdrawal from this study

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: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Aktiv komparator: DJ
Naso disal jejunal(DJ) feedings randomized to 50% of subjects meeting criteria.
Placement of feeding tube through nare and into jejunum for administration of enteral feeding.
Aktiv komparator: NG
Placement of naso gastric feeding tube through nare into stomach for enteral feeding.
Placement of naso gastric feeding tube into stomach for purpose of enteral feedings.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Tidsramme
Feeding success as determined by the quantity of nutrition delivered and the number of interruptions due to intolerance and how the two forms of feeding influence disease outcome as measured by duration of ICU and hospital stay.
Tidsramme: Approx. one week
Approx. one week

Sekundære resultatmål

Resultatmål
Tidsramme
Feeding tolerance (nitrogen balance, stool volume, incidence of nausea, incidence of nausea and vomiting) will demonstrate better tolerance for subjects undergoing DJ feeding than those undergoing NG feeding.
Tidsramme: Approx. one week
Approx. one week

Samarbejdspartnere og efterforskere

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

Efterforskere

  • Ledende efterforsker: David Whitcomb, MD, University of Pittsburgh

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 2010

Primær færdiggørelse (Faktiske)

1. maj 2013

Studieafslutning (Faktiske)

1. maj 2013

Datoer for studieregistrering

Først indsendt

21. december 2007

Først indsendt, der opfyldte QC-kriterier

26. december 2007

Først opslået (Skøn)

27. december 2007

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

27. januar 2016

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

26. januar 2016

Sidst verificeret

1. juni 2013

Mere information

Begreber relateret til denne undersøgelse

Andre undersøgelses-id-numre

  • PRO 07080011, PRO 07080044
  • 1 R01 DK 075803-01A1 NIH#

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 Pancreatitis

Kliniske forsøg med Naso jejunal feeding tube insertion

Abonner