NCT00721604

Brief Summary

The purpose of this study is to verify the accuracy and applicability of predictors of fluid administration efficacy in hypotensive critically ill patients.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
30

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jul 2008

Shorter than P25 for all trials

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

July 1, 2008

Completed
21 days until next milestone

First Submitted

Initial submission to the registry

July 22, 2008

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 24, 2008

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2009

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2009

Completed
Last Updated

August 3, 2009

Status Verified

July 1, 2009

Enrollment Period

9 months

First QC Date

July 22, 2008

Last Update Submit

July 31, 2009

Conditions

HypotensionShock

Keywords

shockfluid responsivenessvolume expansion

Outcome Measures

Primary Outcomes (1)

  • area under ROC curve of pulse pressure variation before volume expansion and their positive and negative predictive values; responders are patients increasing mean arterial pressure

    one hour after the end of fluid administration

Secondary Outcomes (13)

  • area under ROC curve of pulse plethysmographic variation before volume expansion and their positive and negative predictive values; responders are patients increasing mean arterial pressure

    one hour after the end of fluid administration

  • area under ROC curve of pulse pressure variation before volume expansion, positive and negative predictive values; responders are patients showing any clinical improvement

    one hour after the end of fluid administration

  • area under ROC curve of pulse plethysmographic variation before volume expansion, positive and negative predictive values; responders are patients showing any clinical improvement

    one hour after the end of fluid administration

  • area under ROC curve of central venous pressure before volume expansion and their positive and negative predictive values; responders are patients increasing mean arterial pressure

    one hour after the end of fluid administration

  • area under ROC curve of central venous pressure before volume expansion, positive and negative predictive values; responders are patients showing any clinical improvement

    one hour after the end of fluid administration

  • +8 more secondary outcomes

Study Arms (1)

1

patients with mean arterial pressure lower than 65 mmHg

Drug: fluid administration

Interventions

fluid administrationDRUG

two consecutive infusions of 6% hydroxyethyl starch at the dosage 7 ml/kg over 30 minutes (total 14 ml/kg in 60 minutes)

Also known as: Haes Steril, Fresenius Kabi
1

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Hypotensive patients in a General Intensive Care Unit of a University-affiliated hospital. Patients can be recruited only if they have both arterial and central venous catheters

You may qualify if:

  • mean arterial pressure lower than 65 mmHg

You may not qualify if:

  • fluid overload
  • mean arterial pressure lower than 45 mmHg and mandatory immediate treatment
  • active bleeding
  • hemoglobin lower than 8 g.dl-1

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Intensive Care Unit, Fondazione Poliambulanza Istituto Ospedaliero

Brescia, 25124, Italy

Location

Related Publications (1)

  • Natalini G, Rosano A, Militano CR, Di Maio A, Ferretti P, Bertelli M, de Giuli F, Bernardini A. Prediction of arterial pressure increase after fluid challenge. BMC Anesthesiol. 2012 Mar 5;12:3. doi: 10.1186/1471-2253-12-3.

    PMID: 22390818DERIVED

MeSH Terms

Conditions

HypotensionShock

Interventions

HypodermoclysisHydroxyethyl Starch Derivatives

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Infusions, SubcutaneousInfusions, ParenteralDrug Administration RoutesDrug TherapyTherapeuticsFluid TherapyStarchDietary CarbohydratesCarbohydratesGlucansPolysaccharides

Study Officials

  • Giuseppe Natalini, MD

    Fondazione Poliambulanza Istituto Ospedaliero

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

July 22, 2008

First Posted

July 24, 2008

Study Start

July 1, 2008

Primary Completion

April 1, 2009

Study Completion

May 1, 2009

Last Updated

August 3, 2009

Record last verified: 2009-07

Locations

IT(1)