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NAC, NaHCO3 and NS Prophylaxis for CTPA in the ED on Suspicion of PE: A Randomized Controlled Trial

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ClinicalTrials.gov Identifier: NCT02483143
Recruitment Status : Completed
First Posted : June 26, 2015
Last Update Posted : June 26, 2015
Sponsor:
Information provided by (Responsible Party):
Suleyman Turedi, Karadeniz Technical University

Brief Summary:

Study objective:

The purpose of this study was to compare the role of the prophylactic protocols N-acetylcysteine (NAC) plus normal saline, sodium bicarbonate (NaHCO3) plus normal saline and intravenous normal saline (NS) alone in the prevention of contrast-induced nephropathy (CIN) after computed tomography pulmonary angiography (CTPA) in emergency patients with suspected pulmonary embolism (PE).

Materials and methods:

This study was planned as randomized, double blind, placebo controlled clinical research. Patients presenting to the emergency department within a 1-year period, undergoing CTPA on suspicion of PE and having one or more risk factors for development of CIN were included in the study. The NAC group received 1 ml/3 mgr NAC+NS solution 1 h before CTPA and 1 ml/kg per hour for a minimum 6 h after CTPA. The NaHCO3 group received 132 mEq NaHCO3+NS solution for 1 h before CTPA and 1 ml/kg per hour for a minimum of 6h after CTPA. The normal saline (NS) group received 3 ml/kg NS for 1 h before CTPA and 1 ml/kg per hour NS for a minimum 6 h after CTPA. CIN was evaluated as the primary outcome, and moderate renal injury (defined as a 100% increase in serum creatinine levels), severe renal insufficiency requiring hemodialysis or peritoneal dialysis) or in-hospital mortality as secondary outcomes.


Condition or disease Intervention/treatment Phase
Radiographic Contrast Agent Nephropathy Pulmonary Embolism Drug: NAC Drug: NaHCO3 Drug: Normal Saline Phase 4

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 231 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Prevention
Official Title: N-acetylcysteine, Sodium Bicarbonate and Normal Saline Alone Prophylaxis for Spiral Computed Tomography Pulmonary Angiography in the Emergency Department on Suspicion of Pulmonary Emboli: A Randomized Controlled Trial
Study Start Date : February 2014
Actual Primary Completion Date : February 2015
Actual Study Completion Date : February 2015

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: NAC plus normal saline group
1ml/3mgr NAC+NS preCTPA 3 ml/kg for 1 h, 1 ml/kg/h for post CTPA for 6 h
Drug: NAC
3 gr NAC was made up to 1000 ml with NS; a 1 ml/3 mgr NAC solution was obtained and 3 ml/kg NAC+NS solution was administered for 1 h before CTPA and a 1 ml/kg per hour NAC+NS solution was administered for a minimum 6 h after CTPA.
Other Name: N-acetylcysteine

Active Comparator: NaHCO3 plus normal saline group
132 mEq NaHCO3+NS preCTPA 3 ml/kg for 1h, post CTPA 1ml/kg/h for 6 h
Drug: NaHCO3
132 mEq NaHCO3 was made up to 1000 ml with NS; and 3 ml/kg NaHCO3+NS solution was administered for 1 h before CTPA and 1 ml/kg per hour NaHCO3+NS solution was administered for a minimum of 6 h after CTPA.
Other Name: Sodium Bicarbonate

Placebo Comparator: Normal saline alone
preCTPA 3 ml/kg NS for 1h, postCTPA 1ml/kg/h SF for 6 h
Drug: Normal Saline
3 ml/kg NS was administered for 1 h before CTPA and 1 ml/kg per hour was administered for a minimum of 6 h after CTPA.
Other Name: Serum physiologic




Primary Outcome Measures :
  1. Contrast induced nephropathy (CIN) development [ Time Frame: Post contrast 48-72 hour ]
    An increase ≥25% or 0.5 mg/dl in creatinine levels 48-72 h after contrast exposure compared to basal levels


Secondary Outcome Measures :
  1. moderate renal injury developing [ Time Frame: up to 4 weeks, participants were followed for the duration of hospital stay, an expected average of 4 weeks ]
    Number of participants who have 100% increase in serum creatinine levels

  2. severe renal failure developing [ Time Frame: up to 4 weeks, participants will be followed for the duration of hospital stay, an expected average of 4 weeks ]
    Number of participants who require hemodialysis or peritoneal dialysis for the duration of hospital stay

  3. in-hospital mortality [ Time Frame: up to 4 weeks, participants will be followed for the duration of hospital stay, an expected average of 4 weeks ]
    Number of participants who die in the duration of hospital stay hospital. Patients were monitored throughout hospitalization until either discharge or mortality.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion criteria:

  1. Patients undergoing contrast enhanced thoracic tomography due to suspected PE
  2. aged over 18 years old
  3. Measureable basal creatinine levels pre-tomography and measurable serum creatinine levels 48-72 h post-tomography
  4. with one or more of the risk factors for CIN cited below were enrolled.

The risk factors were pre-existing renal dysfunction (Cre 1.4 mg/dl or a high or calculated glomerular filtration rate <60 ml/min/1.73 m2), diabetes mellitus, hypertension receiving treatment, hypotension (SBP<90 mmHg), coronary artery disease, history of nephrotoxic drug use (NSAID, cisplatin, aminoglycoside, amphotericin B), liver disease, congestive heart failure (active or history thereof), age 65 or over, and anemia (Htc <30%).

Exclusion criteria:

  1. Patients refusing to participate or to provide informed consent
  2. End stage renal patients already in peritoneal dialysis or hemodialysis
  3. Pregnant women
  4. Subjects with a known allergy to N-acetylcysteine or Na-bicarbonate
  5. Patients requiring NAC therapy or Na-bicarbonate therapy for existing additional disease
  6. Patients exposed to contrast material for any reason in the previous 2 days were excluded.
  7. If the study protocol was considered by the physician responsible for treatment in the emergency department as being liable to delay medical care or have adverse effects, or if any of the drugs in the protocol were thought to be contraindicated, such patients were also excluded.
  8. Patients unable to receive post-CT infusion for a minimum of 6 h were also excluded.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02483143


Locations
Turkey
Karadeniz Technical University Faculty of Medicine
Trabzon, Turkey, 61080
Sponsors and Collaborators
Karadeniz Technical University
Investigators
Principal Investigator: Suleyman Turedi, Assoc.Prof. Karadeniz Technical University Faculty of Medicine

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Suleyman Turedi, M.D., Karadeniz Technical University
ClinicalTrials.gov Identifier: NCT02483143     History of Changes
Other Study ID Numbers: 2014/47
First Posted: June 26, 2015    Key Record Dates
Last Update Posted: June 26, 2015
Last Verified: June 2015

Keywords provided by Suleyman Turedi, Karadeniz Technical University:
contrast media
pulmonary embolism
N-acetylcysteine

Additional relevant MeSH terms:
Embolism
Pulmonary Embolism
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases
Lung Diseases
Respiratory Tract Diseases
Acetylcysteine
N-monoacetylcystine
Antiviral Agents
Anti-Infective Agents
Expectorants
Respiratory System Agents
Free Radical Scavengers
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents
Physiological Effects of Drugs
Antidotes