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Minimal Volume for Fluid Challenge in Post-operative Patients

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ClinicalTrials.gov Identifier: NCT02569008
Recruitment Status : Completed
First Posted : October 6, 2015
Last Update Posted : October 9, 2015
Sponsor:
Information provided by (Responsible Party):
St George's, University of London

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.

Condition or disease Intervention/treatment Phase
Post Cardiac Surgery Drug: Fluid challenge with Compound Sodium Lactate Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 80 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Diagnostic
Official Title: Study of Changes on Mean Systemic Filling Pressure (Pmsf) in Post-surgical Patients After a Fluid Challenge: Looking for the Minimal Dose of Fluids
Study Start Date : January 2014
Actual Primary Completion Date : February 2015
Actual Study Completion Date : February 2015

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: 1 ml / Kg
Patients receive a Fluid challenge with Compound Sodium Lactate 1 ml/Kg IV over 5 minutes
Drug: Fluid challenge with Compound Sodium Lactate
Infusion of the mentioned dose of Compound sodium Lactate over 5 minutes intravenously.
Other Name: Hartmann's Solution

Experimental: 2 ml/Kg
Patients receive a Fluid challenge with Compound Sodium Lactate 2 ml/Kg IV over 5 minutes
Drug: Fluid challenge with Compound Sodium Lactate
Infusion of the mentioned dose of Compound sodium Lactate over 5 minutes intravenously.
Other Name: Hartmann's Solution

Experimental: 3 ml/Kg
Patients receive a Fluid challenge with Compound Sodium Lactate 3 ml/Kg IV over 5 minutes
Drug: Fluid challenge with Compound Sodium Lactate
Infusion of the mentioned dose of Compound sodium Lactate over 5 minutes intravenously.
Other Name: Hartmann's Solution

Experimental: 4 ml/Kg
Patients receive a Fluid challenge with Compound Sodium Lactate 4 ml/Kg IV over 5 minutes
Drug: Fluid challenge with Compound Sodium Lactate
Infusion of the mentioned dose of Compound sodium Lactate over 5 minutes intravenously.
Other Name: Hartmann's Solution




Primary Outcome Measures :
  1. Proportion of Responders by dose group [ Time Frame: 15 minutes ]
    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)


Secondary Outcome Measures :
  1. Change in Pmsf by dose of fluids [ Time Frame: 15 Minutes ]
    change in Pmsf achieved by each group adjusted by baseline values

  2. Minimal dose of fluids [ Time Frame: 15 Minutes ]
    Estimated minimal dose of fluids required to achieve a significant change in Pmsf



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Ages Eligible for Study:   Child, Adult, Older Adult
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02569008


Locations
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United Kingdom
St George's University Hospitals, NHS Foundation Trust
London, United Kingdom, SW17 0QT
Sponsors and Collaborators
St George's, University of London
Investigators
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Principal Investigator: Hollmann D Aya, M.D. St George's University Hospitals NHS Foundation Trust
Study Director: Maurizio Cecconi, MD(Res) St George's University Hospitals NHS Foundation Trust
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Responsible Party: St George's, University of London
ClinicalTrials.gov Identifier: NCT02569008    
Other Study ID Numbers: 13.0116
First Posted: October 6, 2015    Key Record Dates
Last Update Posted: October 9, 2015
Last Verified: October 2015
Keywords provided by St George's, University of London:
Fluid Challenge
Mean systemic filling pressure
Fluid therapy