CClinicalTrials.gg
CompletedNCT01160627Updated Mar 22, 2013

Prevention of Contrast-induced Nephropathy in Patients With Acute Myocardial Infarction

An interventional study of Hydration and Acetylcysteine in Contrast Induced Nephropathy, sponsored by Odense University Hospital. Completed at 1 site in Denmark. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2013-03-22.

Sponsored by Odense University Hospital · Not applicable, Interventional, and Prevention

Phase
Not applicable
Study type
Interventional
Enrollment
720
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

OBJECTIVE: To evaluate the efficacy of prevention of contrast induced nephropathy in patients with ST segment elevation myocardial infarction treated with primary percutaneous coronary intervention.

DESIGN: Prospective study. SETTING: Three-center study Acute kidney injury was defined as a rise in creatinine >25% from baseline Serum creatinine will be measured at baseline and each day for the following 3 days and at 30 days.

Patients will be randomised to:

  1. Standard treatment
  2. Standard treatment + acetylcystein for 2 days
  3. Standard treatment + Sodium bicarbonate 500 ml / followed by 100 ml/h for 5 hours
  4. Standard treatment + acetylcystein for 2 days + Sodium bicarbonate 500 ml / followed by 100 ml/h for 5 hours
02

Conditions studied

  • Contrast Induced Nephropathy

Keywords

  • CIN STEMI
03

In context

Kidney Diseases

3,840 studies on the registry are indexed under Kidney Diseases; 500 are open to participants now.

This study's enrollment of 720 is above the median of 70 across 2,640 interventional studies indexed under Kidney Diseases.

Browse Kidney Diseases studies →

Lead sponsor

Odense University Hospital is the lead sponsor of 468 studies on the registry; 109 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • STEMI patients treated with primary PCI

Exclusion criteria

Exclusion Criteria:

  • Cardiogenic shock
05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Single group
Masking
None (open label)
Enrollment
720 participants (actual)

Study arms

  • Active comparator
    Standard treatment

    Hydration

    Other: Hydration

  • Active comparator
    Combined Acetylcystein and Sodium Bicarbonat

    Drug: Combined Acetylcystein and Sodium Bicarbonate

  • Active comparator
    Sodium Bicarbonate

    Drug: Sodium bicarbonate

  • Active comparator
    Acetylcystein for 2 days

    Standard treatment + acetylcystein for 2 days

    Drug: Acetylcysteine

Interventions

  • OtherHydration

    Saline hydration

  • DrugAcetylcysteine

    Acetylcystein tablets for 2 days

  • DrugSodium bicarbonate

    Sodium bicarbonate 500 ml followed by 100 ml/hour for 5 hours

  • DrugCombined Acetylcystein and Sodium Bicarbonate

    Sodium bicarbonate 500 ml followed by 100 ml/hour for 5 hours combined with acetylcystein tablets for 2 days

06

What researchers measure

Primary outcomes

  1. Prevention of contrast induced nephropathy in STEMI patients treated with primary PCI

    Rise in creatinine \>25% from baseline to day 3

    Time frame: from baseline to day 3

Secondary outcomes

  1. Prevention of contrast induced nephropathy in STEMI patients treated with primary PCI

    Rise in creatinine \>25% from baseline to day 30

    Time frame: from baseline to day 30

07

Study locations

1 site
  • Odense University Hospital
    Odense, 5000, Denmark
08

References and documents

Publications

  • Thayssen P, Lassen JF, Jensen SE, Hansen KN, Hansen HS, Christiansen EH, Junker A, Ravkilde J, Thuesen L, Veien KT, Jensen LO. Prevention of contrast-induced nephropathy with N-acetylcysteine or sodium bicarbonate in patients with ST-segment-myocardial infarction: a prospective, randomized, open-labeled trial. Circ Cardiovasc Interv. 2014 Apr;7(2):216-24. doi: 10.1161/CIRCINTERVENTIONS.113.000653. Epub 2014 Apr 8. PubMed 24714489 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 22, 2013, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT01160627
Lead sponsor
Odense University Hospital
Responsible party
Lisette Okkels Jensen (MD DMSci PhD, Odense University Hospital) — Principal investigator
First posted
Jul 12, 2010
Start date
Apr 2010
Primary completion
Mar 2013
Completion
Mar 2013
Last update
Mar 22, 2013

Study contacts

Per Thayssen, MD DMSci
principal investigator · Odense University Hospital

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Mar 2013. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion