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
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|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||231 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Care Provider, Investigator)|
|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|
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
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
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
- 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
- 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
- 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
- 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.
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
|Karadeniz Technical University Faculty of Medicine|
|Trabzon, Turkey, 61080|
|Principal Investigator:||Suleyman Turedi, Assoc.Prof.||Karadeniz Technical University Faculty of Medicine|