Minimal Volume for a Fluid Challenge in Septic Patients

NCT02447042 | Completed

• 1 other identifier: 14.0156
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

The administration of fluids intravenously is the first step in the stabilization of patients in septic shock. It is important to give the right dose of fluids, enough to improve the function of the cardiovascular system but not too much to drown the cells in water. In order to know that, the investigators use the "fluid challenge" which is the administration of a "small amount" of fluid in a short period of time in order to test the cardiovascular response to a dose of fluids. However, it is unclear how "small" this amount can be. The aim of this study is to find out the minimum volume required to perform an effective "fluid challenge". The investigators hypothesize that the changes in the mean pressure in the cardiovascular system (socalled mean systemic filling pressure or Pmsf) during the administration of small amounts of fluid can be used to detect the minimum volume required to effectively test the cardiovascular system with a fluid challenge. On the other hand, microcirculation may remain impaired despite the stabilization of the macrocirculation. The microcirculation can be much more dynamic than the macrocriculation, so it is essential to observe the changes of both over time. Patients admitted at the investigators' intensive care unit (ICU) due to sepsis can be included in this study. The sample will be divided in 4 groups according to the volume of the fluid challenge: 2 ml/kg, 3 ml/kg, 4ml/Kg and 5 ml/kg. The investigators will measure the Pmsf non-invasively using a pneumatic tourniquet inflated during one minute. Invasive arterial blood pressure will be observed during the inflation of the cuff in the arm to determine the Pmsf. The least significant change of Pmsf using this method is 14%. The minimal volume will be that one that achieve that change in Pmsf.

Conditions

Sepsis

Keywords

sepsis; Fluids; Mean systemic filling pressure

Outcome Measures

Primary Outcomes (1)

• Change in Pmsf-arm (expressed in percentage from baseline value)

  Inmediately after end of fluid infussion

Secondary Outcomes (2)

• Change in cardiac output (expressed in percentage from baseline value

  Inmmediately after end of fluid infussion

• Proportion of responders in each group

  As average three moths after end of the study

Study Arms (4)

2 ml/Kg

EXPERIMENTAL

Fluid challenge with crystalloids (2 ml/Kg) infused in 5 minutes Measurment of Pmsf-arm before and after the fluid challenge

Procedure: Fluid challenge with crystalloids; Device: Measurement of Pmsf-arm

3 ml/Kg

EXPERIMENTAL

Fluid challenge with crystalloids (3 ml/Kg) infused in 5 minutes Measurment of Pmsf-arm before and after the fluid challenge

Procedure: Fluid challenge with crystalloids; Device: Measurement of Pmsf-arm

4 ml/kg

EXPERIMENTAL

Fluid challenge with crystalloids (4 ml/Kg) infused in 5 minutes Measurment of Pmsf-arm before and after the fluid challenge

Procedure: Fluid challenge with crystalloids; Device: Measurement of Pmsf-arm

5 ml/Kg

EXPERIMENTAL

Fluid challenge with crystalloids (5 ml/Kg) infused in 5 minutes Measurment of Pmsf-arm before and after the fluid challenge

Procedure: Fluid challenge with crystalloids; Device: Measurement of Pmsf-arm

Interventions

Fluid challenge with crystalloids PROCEDURE

Intravenous infusion of 2, 3, 4 or 5 ml/Kg of crystalloids over 5 minutes.

2 ml/Kg; 3 ml/Kg; 4 ml/kg; 5 ml/Kg

Measurement of Pmsf-arm DEVICE

Measurement of stop-flow arterial-venous equilibrium pressure in the arm where the radial arterial pressure is measured by inflating a pneumatic cuff with an automatic pneumatic tourniquet during 60 seconds before and after the fluid challenge in patients receiving 2 ml/Kg, 3 ml/kg, 4 ml/kg and 5 ml/kg of crystalloids in 5 minutes

Also known as: Meassurement of mean systemic filling pressure - arm

2 ml/Kg; 3 ml/Kg; 4 ml/kg; 5 ml/Kg

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Fulfil 2 of 4 of the criteria of the systemic inflammatory response syndrome (SIRS) due to known or suspected infection within the previous 24 hours. The SIRS criteria are:
• Core temperature \>38 °C or \< 36 °C
• Tachycardia (heart rate \> 90 beats per minute)
• Tachypnoea (respiratory rate \>20 breaths per minute or PaCO2 \< 4.3 kPa or need for mechanical ventilation)
• Abnormal white cell count (\> 12000 cells/mm3 or \< 4000 cells/mm3, or \>10% immature (band cells) forms.

You may not qualify if:

• Extensive peripheral arterial occlusive disease in upper limbs.
• Postoperative valvular insufficiency
• Aortic valve regurgitation
• Tachyarrhythmia
• Cardiac assist device (IntraAortic balloon pump)
• Previously known right ventricular failure
• Known vasospastic diseases, systemic sclerosis or Raynaud's phenomenon.
• Patients requiring aggressive fluid resuscitation due to lifethreatening cardiovascular instability
• Known pregnant women.

Sponsors & Collaborators

• St George's, University of London: lead

Study Sites (1)

St George's University Hospitals, NHS Foundation Trust

London, London, SW17 0QT, United Kingdom

Location

Related Publications (3)

• GUYTON AC. Determination of cardiac output by equating venous return curves with cardiac response curves. Physiol Rev. 1955 Jan;35(1):123-9. doi: 10.1152/physrev.1955.35.1.123. No abstract available.

  PMID: 14356924 BACKGROUND

• Pinsky MR. Instantaneous venous return curves in an intact canine preparation. J Appl Physiol Respir Environ Exerc Physiol. 1984 Mar;56(3):765-71. doi: 10.1152/jappl.1984.56.3.765.

  PMID: 6368503 BACKGROUND

• Maas JJ, Geerts BF, van den Berg PC, Pinsky MR, Jansen JR. Assessment of venous return curve and mean systemic filling pressure in postoperative cardiac surgery patients. Crit Care Med. 2009 Mar;37(3):912-8. doi: 10.1097/CCM.0b013e3181961481.

  PMID: 19237896 BACKGROUND

MeSH Terms

Conditions

Sepsis

Interventions

Crystalloid Solutions

Condition Hierarchy (Ancestors)

Infections; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Officials

• Hollmann D Aya, MD

  St George's University Hospitals NHS Foundation Trust

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Fellow Intensive Care Directorate

Study Record Dates

• First Submitted: May 11, 2015
• First Posted: May 18, 2015
• Study Start: November 1, 2014
• Primary Completion: February 1, 2016
• Study Completion: February 1, 2016
• Last Updated: October 14, 2016

Record last verified: 2016-10

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)