Oral Salt and Water to Prevent Contrast Nephropathy

NCT02084771 | Withdrawn Phase 4 DMC

• 1 other identifier: OHRI-1777
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this pilot trial is to determine the safety and feasibility of using oral salt and water loading compared to intravenous saline for the prevention of contrast-induced acute kidney injury in patients with chronic kidney disease receiving a contrast-enhanced CT scan.

Conditions

Acute Kidney Injury

Keywords

contrast nephropathy; contrast induced acute kidney injury; acute kidney injury; prophylaxis; randomized trial

Outcome Measures

Primary Outcomes (1)

• Feasibility (recruitment rate, adherence to intervention and completeness of follow-up)

  The primary outcome for this pilot trial is feasibility (recruitment rate, adherence to intervention and completeness of follow-up). We will aim to establish that 1. We can randomize 50 patients into this trial; 2. Trial participants have \>95% adherence to the fluid regimens and 3. After randomization, \<1% participants are lost to follow-up in terms of post-CT serum creatinine measurements.

  24 months

Secondary Outcomes (1)

• Safety

  24 months

Study Arms (2)

Oral Salt and Water

EXPERIMENTAL

Oral Salt and Water Loading: Participants randomized to this arm of the trial will receive 0.1 g/kg of salt (NaCl) and 12 mL/kg of water. Patients weighing more than 110 kg will receive the same amount as per a 110 kg patient. One third of the oral salt and water will be given before the CT and 2/3 post-CT as in the intravenous saline arm. Specifically, 0.03 g/kg of NaCl and 4 mL/kg of water in the one hour before CT and 0.07 g/kg of NaCl and 8 mL/kg of water taken over 2 hours post-CT. The ingestion of the oral salt and water will be directly observed by the study nurse to ensure adherence to the protocol.

Biological: Oral Salt and Water

Intravenous Saline

ACTIVE COMPARATOR

Patients randomized to this arm will receive intravenous isotonic (0.9%) saline. The rate of isotonic saline will be 3 mL/kg give in the one hour before CT and 1 mL/kg/hour for 6 hours post-CT as per Canadian guidelines. Patients weighing more than 110 kg will receive the rate as per a 110 kg patient. The dose will be rounded up to the nearest 5 mL.

Drug: Intravenous Saline

Interventions

Intravenous Saline DRUG

Patients randomized to this arm will receive intravenous isotonic (0.9%) saline. The rate of isotonic saline will be 3 mL/kg given the one hour before CT and 1 mL/kg/hour for 6 hours post-CT as per Canadian guidelines. Patients weighing more than 110 kg will receive the rate as per a 110 kg patient. The dose will be rounded up to the nearest 5 mL.

Also known as: normal saline, 0.9% saline, intravenous hydration, volume expansion

Intravenous Saline

Oral Salt and Water BIOLOGICAL

Oral salt capsules and water, based on patient weight

Oral Salt and Water

Eligibility Criteria

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

You may qualify if:

• Chronic kidney disease (as defined by glomerular filtration rate (GFR) \< 45 mL/min/1.73m2 using the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) formula calculated on the day of randomization);
• Undergoing an outpatient intravenous contrast-enhanced CT of the chest or abdomen;
• Age ≥ 18 years

You may not qualify if:

• Inability to give informed consent;
• Previously enrolled in this study;
• Any contrast-enhanced test in previous 14 days (to exclude patients who might have ongoing AKI from previous contrast exposure) ;
• Congestive heart failure defined as New York Heart Association (NYHA) class III or worse 76;
• Uncontrolled hypertension defined as systolic blood pressure greater than 180 mm Hg or diastolic blood pressure greater than 110 mm Hg at screening;
• Receiving dialysis treatments.
• The Physician ordering the CT scan has also ordered IV Saline, sodium bicarbonate or n-acetyl cysteine.

Sponsors & Collaborators

• Ottawa Hospital Research Institute: lead

Study Sites (1)

Ottawa Hospital Research Institute

Ottawa, Ontario, K1H7W9, Canada

Location

Related Publications (1)

• Swapnil H, Knoll GA, Kayibanda JF, Fergusson D, Chow BJ, Shabana W, Murphy E, Ramsay T, James M, White CA, Garg A, Wald R, Hoch J, Akbari A. Oral salt and water versus intravenous saline for the prevention of acute kidney injury following contrast-enhanced computed tomography: study protocol for a pilot randomized trial. Can J Kidney Health Dis. 2015 Apr 16;2:12. doi: 10.1186/s40697-015-0048-7. eCollection 2015.

  PMID: 25883789 BACKGROUND

MeSH Terms

Conditions

Acute Kidney Injury

Interventions

Saline Solution; Salts; Water

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations; Inorganic Chemicals; Hydroxides; Alkalies; Anions; Ions; Electrolytes; Oxides; Oxygen Compounds

Study Officials

• Swapnil Hiremath, MD MPH

  Ottawa Hospital Research Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 5, 2013
• First Posted: March 12, 2014
• Study Start: October 1, 2014
• Primary Completion: December 1, 2015
• Study Completion: June 1, 2016
• Last Updated: March 31, 2016

Record last verified: 2016-03

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)