NCT01742130

Brief Summary

The purpose of this study is to determine whether hydration with sodium bicarbonate is more effective than hydration with sodium chloride to prevent contrast nephropathy in patients undergoing primary coronary intervention for acute ST elevation myocardial infarction.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
300

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Jan 2011

Typical duration for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2011

Completed
1.9 years until next milestone

First Submitted

Initial submission to the registry

December 2, 2012

Completed
3 days until next milestone

First Posted

Study publicly available on registry

December 5, 2012

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2013

Completed
Last Updated

November 7, 2013

Status Verified

November 1, 2013

Enrollment Period

2.8 years

First QC Date

December 2, 2012

Last Update Submit

November 5, 2013

Conditions

Contrast Induced Acute Kidney Injury

Keywords

Contrast-induced nephropathyContrast mediaAngiographyCoronary percutaneous intervention

Outcome Measures

Primary Outcomes (1)

  • Incidence of contrast-induced acute kidney injury

    contrast-induced acute kidney injury is defined as an increase in serum creatinine \>= 0.3 mg/dL over the baseline value within 2 days after the administration of the contrast medium

    2 days

Secondary Outcomes (1)

  • adverse clinical events

    1 month

Study Arms (2)

Sodium bicarbonate

EXPERIMENTAL

Sodium Bicarbonate (154 mEq/L in dextrose and H2O) 3 mL/kg for 1 hour before contrast medium, followed by an infusion of 1 mL/kg/h for 12 hours after the procedure

Drug: sodium bicarbonate solution

Saline

ACTIVE COMPARATOR

Sodium Saline 3 mL/kg for 1 hour before contrast medium, followed by an infusion of 1 mL/kg/h for 12 hours after the procedure

Drug: Isotonic saline

Interventions

sodium bicarbonate solutionDRUG
Also known as: 154 mEq/L in dextrose and H2O
Sodium bicarbonate
Isotonic salineDRUG
Also known as: 0.9% sodium chloride
Saline

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Consecutive patients with AMI candidates for primary PCI presenting within 12 h of symptom onset with ST-segment elevation of more 1 mm in at least two contiguous leads of electrocardiogram.

You may not qualify if:

  • contrast medium administration within the 10 days
  • end-stage renal failure requiring dialysis
  • refusal to give informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ospedale Misericordia e Dolce

Prato, Prato, 59100, Italy

Location

MeSH Terms

Interventions

GlucoseSodium Chloride

Intervention Hierarchy (Ancestors)

HexosesMonosaccharidesSugarsCarbohydratesChloridesHydrochloric AcidChlorine CompoundsInorganic ChemicalsSodium Compounds

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
PRINCIPAL INVESTIGATOR
PI Title
Medical Doctor

Study Record Dates

First Submitted

December 2, 2012

First Posted

December 5, 2012

Study Start

January 1, 2011

Primary Completion

October 1, 2013

Study Completion

October 1, 2013

Last Updated

November 7, 2013

Record last verified: 2013-11

Locations

IT(1)