NCT02225431

Brief Summary

The aim of this study was to evaluate, in patients with "lower fluid status" defined by bioimpedance analysis, whether two different protocol of IV isotonic saline infusion are associated with different volume expansion and differing risks for CI-AKI in patients undergoing coronary angiographic procedures.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
296

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Sep 2012

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

September 1, 2012

Completed
2 years until next milestone

First Submitted

Initial submission to the registry

August 24, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 26, 2014

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2015

Completed
Last Updated

October 16, 2015

Status Verified

October 1, 2015

Enrollment Period

2.6 years

First QC Date

August 24, 2014

Last Update Submit

October 15, 2015

Conditions

Acute Kidney Injury

Keywords

Contrast-induced nephropathyContrast-Induced acute kidney injuryContrast mediaAngiographyCoronary percutaneous intervention

Outcome Measures

Primary Outcomes (1)

  • Incidence of contrast-induced acute kidney injury

    contrast acute kidney injury is defined as an increase in serum Cystatin C concentration 10% above the baseline value at 24 hours after administration of contrast medium

    1 day

Secondary Outcomes (1)

  • Adverse clinical events

    1 month

Other Outcomes (1)

  • Incidence of contrast-induced acute kidney injury

    2 days

Study Arms (2)

Standard saline infusion

ACTIVE COMPARATOR

All patients received standard intravenous saline hydration (0.9% sodium chloride, 1 ml/kg/h for 12 hours before and after procedure)

Drug: sodium chloride infusion

Double saline infusion

EXPERIMENTAL

All patients received double dose of intravenous saline hydration (0.9% sodium chloride, 2 ml/kg/h for 12 hours before and after procedure)

Drug: sodium chloride infusion

Interventions

sodium chloride infusionDRUG
Double saline infusionStandard saline infusion

Eligibility Criteria

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

You may qualify if:

  • consecutive patients admitted in Cardiology Unit for coronary or peripheral angiography with "lower fluid status" defined on the basis bio-impedance analysis (Male with resistance/height ratio \> 315 Ohm/meter and Female \> 380 Ohm/meter).

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ospedale Santo Stefano

Prato, Prato, 59100, Italy

Location

Related Publications (2)

  • Maioli M, Toso A, Leoncini M, Musilli N, Bellandi F, Rosner MH, McCullough PA, Ronco C. Pre-procedural bioimpedance vectorial analysis of fluid status and prediction of contrast-induced acute kidney injury. J Am Coll Cardiol. 2014 Apr 15;63(14):1387-94. doi: 10.1016/j.jacc.2014.01.025. Epub 2014 Feb 12.

    PMID: 24530668BACKGROUND

  • Maioli M, Toso A, Leoncini M, Musilli N, Grippo G, Ronco C, McCullough PA, Bellandi F. Bioimpedance-Guided Hydration for the Prevention of Contrast-Induced Kidney Injury: The HYDRA Study. J Am Coll Cardiol. 2018 Jun 26;71(25):2880-2889. doi: 10.1016/j.jacc.2018.04.022.

    PMID: 29929610DERIVED

MeSH Terms

Conditions

Acute Kidney Injury

Condition Hierarchy (Ancestors)

Renal InsufficiencyKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital Diseases

Study Officials

  • Mauro Maioli, MD

    Ospedale S. Stefano - Prato - Italy

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

August 24, 2014

First Posted

August 26, 2014

Study Start

September 1, 2012

Primary Completion

April 1, 2015

Study Completion

April 1, 2015

Last Updated

October 16, 2015

Record last verified: 2015-10

Locations

IT(1)