NCT02569008

Brief Summary

This study evaluate the effect of different doses of crystalloids on the changes on cardiac output (CO) and on the proportion of responders and non-responders and aims to determine the minimal volume required to increase the mean systemic filling pressures (Pmsf) in post-cardiac surgical patients.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2014

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, 2014

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2015

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

October 2, 2015

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 6, 2015

Completed
Last Updated

October 9, 2015

Status Verified

October 1, 2015

Enrollment Period

1.1 years

First QC Date

October 2, 2015

Last Update Submit

October 8, 2015

Conditions

Post Cardiac Surgery

Keywords

Fluid ChallengeMean systemic filling pressureFluid therapy

Outcome Measures

Primary Outcomes (1)

  • Proportion of Responders by dose group

    Proportion of responders to a fluid challenge by dose of crystalloids according to CO response (greater than 10% change in CO is a positive response)

    15 minutes

Secondary Outcomes (2)

  • Change in Pmsf by dose of fluids

    15 Minutes

  • Minimal dose of fluids

    15 Minutes

Study Arms (4)

1 ml / Kg

EXPERIMENTAL

Patients receive a Fluid challenge with Compound Sodium Lactate 1 ml/Kg IV over 5 minutes

Drug: Fluid challenge with Compound Sodium Lactate

2 ml/Kg

EXPERIMENTAL

Patients receive a Fluid challenge with Compound Sodium Lactate 2 ml/Kg IV over 5 minutes

Drug: Fluid challenge with Compound Sodium Lactate

3 ml/Kg

EXPERIMENTAL

Patients receive a Fluid challenge with Compound Sodium Lactate 3 ml/Kg IV over 5 minutes

Drug: Fluid challenge with Compound Sodium Lactate

4 ml/Kg

EXPERIMENTAL

Patients receive a Fluid challenge with Compound Sodium Lactate 4 ml/Kg IV over 5 minutes

Drug: Fluid challenge with Compound Sodium Lactate

Interventions

Fluid challenge with Compound Sodium LactateDRUG

Infusion of the mentioned dose of Compound sodium Lactate over 5 minutes intravenously.

Also known as: Hartmann's Solution
1 ml / Kg2 ml/Kg3 ml/Kg4 ml/Kg

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Patients admitted to the general or cardiothoracic intensive care unit, requiring fluid therapy guided by the current clinical protocol.

You may not qualify if:

  • Extensive peripheral arterial occlusive disease in upper limbs.
  • Postoperative valvular insufficiency
  • Aortic valve regurgitation
  • Arrhythmia
  • Cardiac assist device (Intra-Aortic balloon pump)
  • Right ventricular failure
  • Patients without capacity to consent for themselves Also, patients requiring aggressive fluid resuscitation due to life-threatening cardiovascular instability and pregnant women will be excluded from the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

St George's University Hospitals, NHS Foundation Trust

London, London, SW17 0QT, United Kingdom

Location

MeSH Terms

Interventions

Ringer's Lactate

Intervention Hierarchy (Ancestors)

Crystalloid SolutionsIsotonic SolutionsSolutionsPharmaceutical Preparations

Study Officials

  • Hollmann D Aya, M.D.

    St George's University Hospitals NHS Foundation Trust

    PRINCIPAL INVESTIGATOR

  • Maurizio Cecconi, MD(Res)

    St George's University Hospitals NHS Foundation Trust

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 2, 2015

First Posted

October 6, 2015

Study Start

January 1, 2014

Primary Completion

February 1, 2015

Study Completion

February 1, 2015

Last Updated

October 9, 2015

Record last verified: 2015-10

Locations

GB(1)