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

• Status: Completed
• Trial end date: 2015-02-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Karadeniz Technical University
• Treatments: Acetylcysteine; N-monoacetylcystine

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.