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

NCT02483143 | Completed Phase 4

• 1 other identifier: 2014/47
• Study Type: interventional
• Target: 231
• Locations: 1 country
• Sites: 1

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.

Conditions

Radiographic Contrast Agent Nephropathy; Pulmonary Embolism

Keywords

contrast media; pulmonary embolism; N-acetylcysteine

Outcome Measures

Primary Outcomes (1)

• Contrast induced nephropathy (CIN) development

  An increase ≥25% or 0.5 mg/dl in creatinine levels 48-72 h after contrast exposure compared to basal levels

  Post contrast 48-72 hour

Secondary Outcomes (3)

• moderate renal injury developing

  up to 4 weeks, participants were followed for the duration of hospital stay, an expected average of 4 weeks

• severe renal failure developing

  up to 4 weeks, participants will be followed for the duration of hospital stay, an expected average of 4 weeks

• in-hospital mortality

  up to 4 weeks, participants will be followed for the duration of hospital stay, an expected average of 4 weeks

Study Arms (3)

NAC plus normal saline group

ACTIVE COMPARATOR

1ml/3mgr NAC+NS preCTPA 3 ml/kg for 1 h, 1 ml/kg/h for post CTPA for 6 h

Drug: NAC

NaHCO3 plus normal saline group

ACTIVE COMPARATOR

132 mEq NaHCO3+NS preCTPA 3 ml/kg for 1h, post CTPA 1ml/kg/h for 6 h

Drug: NaHCO3

Normal saline alone

PLACEBO COMPARATOR

preCTPA 3 ml/kg NS for 1h, postCTPA 1ml/kg/h SF for 6 h

Drug: Normal Saline

Interventions

NAC DRUG

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.

Also known as: N-acetylcysteine

NAC plus normal saline group

NaHCO3 DRUG

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.

Also known as: Sodium Bicarbonate

NaHCO3 plus normal saline group

Normal Saline DRUG

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.

Also known as: Serum physiologic

Normal saline alone

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients undergoing contrast enhanced thoracic tomography due to suspected PE
• aged over 18 years old
• Measureable basal creatinine levels pre-tomography and measurable serum creatinine levels 48-72 h post-tomography
• 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%).

You may not qualify if:

• Patients refusing to participate or to provide informed consent
• End stage renal patients already in peritoneal dialysis or hemodialysis
• Pregnant women
• Subjects with a known allergy to N-acetylcysteine or Na-bicarbonate
• Patients requiring NAC therapy or Na-bicarbonate therapy for existing additional disease
• Patients exposed to contrast material for any reason in the previous 2 days were excluded.
• 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.
• Patients unable to receive post-CT infusion for a minimum of 6 h were also excluded.

Sponsors & Collaborators

• Karadeniz Technical University: lead

Study Sites (1)

Karadeniz Technical University Faculty of Medicine

Trabzon, 61080, Turkey (Türkiye)

Location

Related Publications (1)

• Turedi S, Erdem E, Karaca Y, Tatli O, Sahin A, Turkmen S, Gunduz A. The High Risk of Contrast-induced Nephropathy in Patients with Suspected Pulmonary Embolism Despite Three Different Prophylaxis: A Randomized Controlled Trial. Acad Emerg Med. 2016 Oct;23(10):1136-1145. doi: 10.1111/acem.13051. Epub 2016 Sep 27.

  PMID: 27411777 DERIVED

MeSH Terms

Conditions

Pulmonary Embolism

Interventions

Acetylcysteine; Sodium Bicarbonate; Saline Solution

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Embolism; Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Cysteine; Amino Acids, Sulfur; Sulfur Compounds; Organic Chemicals; Amino Acids; Amino Acids, Peptides, and Proteins; Bicarbonates; Carbonates; Carbonic Acid; Carbon Compounds, Inorganic; Inorganic Chemicals; Sodium Compounds; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Officials

• Suleyman Turedi, Assoc.Prof.

  Karadeniz Technical University Faculty of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: M.D.

Study Record Dates

• First Submitted: May 27, 2015
• First Posted: June 26, 2015
• Study Start: February 1, 2014
• Primary Completion: February 1, 2015
• Study Completion: February 1, 2015
• Last Updated: June 26, 2015

Record last verified: 2015-06

Locations

TU (1)