- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT00830193
N-Acetylcysteine in Critically Ill Patients Undergoing Contrast Enhanced Computed Tomography
N-Acetylcysteine in Critically Ill Patients Undergoing Contrast Enhanced Computed Tomography: A Randomized Trial
Studieöversikt
Status
Betingelser
Intervention / Behandling
Detaljerad beskrivning
Potential participants were identified by staff intensivists or resident physicians following admission to participating ICUs. We included critically ill adult patients at least 18 years of age who consented to participate in the trial, had central venous access and a foley catheter, required a contrast-enhanced CT of any organ system(s), and were considered 'at risk' for the development of CIN. We defined 'at risk' to include patients with at least one of the following at the time of randomization (i) a serum creatinine of > 106 µmol/L and or urea > 6 mmol/L, (ii) urine output of < 0.5 cc/kg over > 4 hrs or (iii) an increase in serum creatinine of > 50 µmol/L in < 24 hours. We stratified based on the presence or absence of diabetes defined as a history of treatment with oral hypoglycemics or insulin.
We excluded patients with a (i) CK > 5,000 or the presence of myoglobinuria, (ii) a known allergy or hypersensitivity reaction to radiographic contrast dye or NAC, (iii) serious illness with imminent threat of dying (low likelihood of survival within 48-hours) or poor prognosis, (iv) pregnancy, (v) patients with cardiogenic shock (NYHA class 3 or 4 symptoms), (vi) known or suspected nephritic, nephrotic or pulmonary-renal syndromes, (vii) a post renal etiology of renal impairment, (viii) previous renal transplant, (ix) known solitary kidney, (x) serum creatinine > 200 µmol/L or (xi) recent exposure to radiographic contrast within 14 days of randomization.
The primary outcome for the study was the development of CIN defined as a rise in serum creatinine of > 50 µmol/L from the time of randomization up to day 5 following contrast exposure.
Secondary outcomes included ICU and hospital length of stay, ICU and hospital mortality and the requirement for renal replacement therapy. We recorded compliance with assigned treatment and assessed for development of severe unexpected adverse events defined as hypotension, bronchospasm and anaphylactic reactions.
Studietyp
Inskrivning (Faktisk)
Fas
- Fas 2
- Fas 3
Kontakter och platser
Studieorter
-
-
Ontario
-
London, Ontario, Kanada, N6A 4G5
- London Health Sciences Centre - Victoria Hospital
-
London, Ontario, Kanada, N6A 5A5
- London Health Sciences Centre - University Hospital Campus
-
-
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Beskrivning
Inclusion Criteria:
- The investigators included critically ill adult patients at least 18 years of age who consented to participate in the trial, had central venous access and a foley catheter, required a contrast-enhanced CT of any organ system(s), and were considered 'at risk' for the development of CIN.
- The investigators defined 'at risk' to include patients with at least one of the following at the time of randomization (i) a serum creatinine of > 106 µmol/L and or urea > 6 mmol/L, (ii) urine output of < 0.5 cc/kg over > 4 hrs or (iii) an increase in serum creatinine of > 50 µmol/L in < 24 hours.
Exclusion Criteria:
The investigators excluded patients with a
- CK > 5,000 or the presence of myoglobinuria
- a known allergy or hypersensitivity reaction to radiographic contrast dye or NAC
- serious illness with imminent threat of dying (low likelihood of survival within 48-hours) or poor prognosis
- pregnancy
- patients with cardiogenic shock (NYHA class 3 or 4 symptoms)
- known or suspected nephritic, nephrotic or pulmonary-renal syndromes
- a post renal etiology of renal impairment
- previous renal transplant
- known solitary kidney
- serum creatinine > 200 µmol/L or (xi) recent exposure to radiographic contrast within 14 days of randomization.
Studieplan
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Förebyggande
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Fyrdubbla
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
---|---|
Aktiv komparator: N-acetylcysteine
Intravenous fluid administration was administered as soon as possible following randomization (not to exceed 12 hours prior to anticipated contrast exposure) and continued for 12 hours post CT.
Patients randomized to the experimental arm received intravenous normal saline plus NAC 10 grams IV (5 g pre and 2.5 g at 6 and 12 hours post-exposure) for a total of 3 doses.
|
Medication packages were prepared and dispensed by pharmacy and included three premixed and prepackaged minibags containing either 5 g of NAC or placebo in 100 cc D5W (pre-CT dose) or 2.5 g of NAC or placebo in 50 cc D5W (post-CT doses).
Andra namn:
|
Placebo-jämförare: Placebo
Intravenous fluid administration was administered as soon as possible following randomization (not to exceed 12 hours prior to anticipated contrast exposure) and continued for 12 hours post CT.
Medication packages were prepared and dispensed by pharmacy and included three premixed and prepackaged minibags containing either 5 g in 100 cc D5W (pre-CT dose) or 2.5 g in 50 cc D5W (post-CT doses).
The placebo was D5W and was colour and consistency matched by pharmacy.
Patients randomized to placebo received intravenous normal saline plus 3 doses of placebo.
|
Medication packages were prepared and dispensed by pharmacy and included three premixed and prepackaged minibags containing either 5 g of NAC or placebo (D5W) in 100 cc D5W (pre-CT dose) or 2.5 g NAC or placebo in 50 cc D5W (post-CT doses).
Andra namn:
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Tidsram |
---|---|
The primary outcome for the study was the development of CIN defined as a rise in serum creatinine of > 50 µmol/L from the time of randomization up to day 5 following contrast exposure.
Tidsram: 5 days
|
5 days
|
Sekundära resultatmått
Resultatmått |
Tidsram |
---|---|
ICU length of stay
Tidsram: ICU stay
|
ICU stay
|
Hospital length of stay
Tidsram: Hospital stay
|
Hospital stay
|
ICU-dödlighet
Tidsram: ICU stanna
|
ICU stanna
|
Hospital Mortality
Tidsram: Hospital stay
|
Hospital stay
|
Requirement for Renal Replacement Therapy
Tidsram: ICU
|
ICU
|
Samarbetspartners och utredare
Sponsor
Utredare
- Studierektor: Claudio M Martin, MD, FRCPC, MSc, London Health Sciences Centre - Victoria Hospital
Studieavstämningsdatum
Studera stora datum
Studiestart
Primärt slutförande (Faktisk)
Avslutad studie (Faktisk)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Uppskatta)
Uppdateringar av studier
Senaste uppdatering publicerad (Uppskatta)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
- Patologiska processer
- Urologiska sjukdomar
- Sjukdomsegenskaper
- Njursjukdomar
- Kritisk sjukdom
- Läkemedels fysiologiska effekter
- Molekylära mekanismer för farmakologisk verkan
- Anti-infektionsmedel
- Antivirala medel
- Skyddsmedel
- Andningsorgan
- Antioxidanter
- Motgift
- Free Radical Scavengers
- Slemlösande medel
- Acetylcystein
- N-monoacetylcystin
Andra studie-ID-nummer
- LHRI-000001
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