NCT02792387

Brief Summary

The aim of the study is to explore association between increased central venous pressure, Ejection Fraction and renal dysfunction (eGFR) in patients with Cardio-Renal Syndromes type 1 and 2. The pilot study was set to provide the expected correlation coefficient for a sample size determination of the subsequent study.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
11

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Sep 2015

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2015

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2016

Completed
15 days until next milestone

First Submitted

Initial submission to the registry

May 16, 2016

Completed
22 days until next milestone

First Posted

Study publicly available on registry

June 7, 2016

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2017

Completed
Last Updated

October 11, 2017

Status Verified

October 1, 2017

Enrollment Period

8 months

First QC Date

May 16, 2016

Last Update Submit

October 10, 2017

Conditions

Heart Failure

Keywords

cardio-renal syndromeright heart dysfunctioncentral venous pressureeGFRlow-flow theory

Outcome Measures

Primary Outcomes (1)

  • renal impairment (defined as a Glomerular Filtration Rate less than 60 mL/min per 1.73 m2)

    Estimated Glomerular Filtration Rate has been assessed with the Modification of Diet in Renal Disease formula

    through study completion, an average of 1 year

Interventions

CVP measurementOTHER

CVP measurements had been performed with an electronic pressure transducer in spontaneously breathing non-ventilated patients. Central vein access was established trough the subclavian or internal jugular veins. Mean CVP was recorded for each patient, measured in mmHg.

Eligibility Criteria

Age18 Years - 100 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

patients who underwent in-patient treatment at medical centers

You may qualify if:

  • HF (NYHA class I - IV, with preserved and reduced EF) and reduced GFR (Cardio-Renal Syndromes 1 and 2)

You may not qualify if:

  • Independent risk factors for renal impairment (e.g. diabetes, sepsis)
  • Primary nephropathy or secondary nephropathy due to diseases other than HF

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Heart FailureCardio-Renal Syndrome

Interventions

Central Venous Pressure

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular DiseasesRenal InsufficiencyKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital Diseases

Intervention Hierarchy (Ancestors)

Venous PressureBlood PressureHemodynamicsCardiovascular Physiological PhenomenaCirculatory and Respiratory Physiological Phenomena

Study Officials

  • George Lobzhanidze, MD

    Tbilisi State University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

May 16, 2016

First Posted

June 7, 2016

Study Start

September 1, 2015

Primary Completion

May 1, 2016

Study Completion

January 1, 2017

Last Updated

October 11, 2017

Record last verified: 2017-10

Data Sharing

IPD Sharing
Will not share