The Impact of the pH on Cardiac Function in the Critically Ill Patient

NCT04231045 | Completed FDA Device

• 1 other identifier: 227870
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 2

Brief Summary

Study Title: The Impact of the pH on cardiac function in the critically ill patient Sponsor: King's College Hospital NHS Foundation Trust Chief Investigator: Dr Sancho Rodríguez-Villar IRAS Number: 227870 Hypothesis: Titration studies in animals with normal cardiac function show that a reduction in blood pH (and presumably that of the intracellular and interstitial compartments) from the normal level of 7.40 to 7.20 is associated with a rise in cardiac output. However, when blood pH is less than 7.20, cardiac output is reduced. Similar studies in humans with or without normal cardiac function have not been done, and yet blood pH at which aggressive treatment is recommended has been set at 7.20 based solely on animal experiments. The investigators hypothesize that a change in blood pH in humans will also affect cardiac function, but the level of blood pH at which this is observed might be similar or different in humans. In addition, the presence or absence of underlying cardiac disease and the type of acid-base abnormality present might modify the response of the heart to changes in blood pH. Primary Objectives:

1. 1.Assess whether there are significant changes in cardiac function associated with changes in blood pH.
2. 2.Relate the changes in cardiac function to the presence or absence of underlying cardiac disease.

Conditions

Acidosis; Cardiac; Deficiency; Acid Base Disorder

Keywords

acidosis; cardiac contractility; acid-base disorder

Outcome Measures

Primary Outcomes (3)

• Assess whether there are significant changes in stroke volume index associated with changes in blood pH using PiCCO technology monitoring.

  SVI- Stroke Volumen Index (40-60 mL/ m2)

  within 24 hours of being started on the PICCO monitoring system through cardiovascular monitoring study completion, an average of 5 days per patient

• Assess whether there are significant changes in CI -Cardiac index or PCCI are associated with changes in blood pH using PiCCO technology monitoring.

  CI (Cardiac index or PCCI): 3-5 L/min/m2

  within 24 hours of being started on the PICCO monitoring system through cardiovascular monitoring study completion, an average of 5 days per patient

• Assess whether there are significant changes in CO-Cardiac Output or PCCO are associated with changes in blood pH using PiCCO technology monitoring.

  CO (Cardiac Output or PCCO): 4 - 8 L/min

  within 24 hours of being started on the PICCO monitoring system through cardiovascular monitoring study completion, an average of 5 days per patient

Secondary Outcomes (4)

• Assess whether there are significant changes in cardiac contractility measuring the GEF (Global ejection fraction) are associated with changes in blood pH using PiCCO technology monitoring.

  within 24 hours of being started on the PICCO monitoring system through cardiovascular monitoring study completion, an average of 5 days per patient

• Assess whether there are significant changes in cardiac contractility measuring the dPmx (Index of Left Ventricular Contractility) are associated with changes in blood pH using PiCCO technology monitoring.

  within 24 hours of being started on the PICCO monitoring system through cardiovascular monitoring study completion, an average of 5 days per patient

• Assess whether there are significant changes in cardiac contractility measuring the CFI (Cardiac function index) are associated with changes in blood pH using PiCCO technology monitoring.

  within 24 hours of being started on the PICCO monitoring system through cardiovascular monitoring study completion, an average of 5 days per patient

• Assess whether there are significant changes in cardiac contractility measuring the CPI (Cardiac Power Index) are associated with changes in blood pH using PiCCO technology monitoring.

  within 24 hours of being started on the PICCO monitoring system through cardiovascular monitoring study completion, an average of 5 days per patient

Other Outcomes (2)

• Assess whether there are significant changes in the preload measuring the ITBVI (Intra thoracic blood volume index) are associated with changes in CO-Cardiac Output PCCO or blood pH using PiCCO technology monitoring.

  within 24 hours of being started on the PICCO monitoring system through cardiovascular monitoring study completion, an average of 5 days per patient

• Assess whether there are significant changes in the preload measuring the GEDI (Global end-diastolic volume index) are associated with changes in CO-Cardiac Output PCCO or blood pH using PiCCO technology monitoring.

  within 24 hours of being started on the PICCO monitoring system through cardiovascular monitoring study completion, an average of 5 days per patient

Study Arms (1)

Patients on PiCCO monitoring system

ALL intensive care patients on PiCCO monitoring system and over 18 years old and on PiCCO for more than 24 hours. Those medical or surgical patients admitted in a UK NHS unit, elective, semi-elective or emergency admission.

Device: PiCCO device cardiac monitoring

Interventions

PiCCO device cardiac monitoring DEVICE

PiCCO is a cardiac output monitor that combines pulse contour analysis and transpulmonary thermodilution technique.Haemodynamic monitoring especially if complex mixed forms of shock (e.g. septic and cardiogenic) PAC unavailable or contra-indicated

Patients on PiCCO monitoring system

Eligibility Criteria

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

Study Population

UK NHS (National Health service) patients admitted to ICU over 18 years old

You may qualify if:

• Over 18 years old.
• On PiCCO for more than 24 hours

You may not qualify if:

• ALL patients WITHOUT PiCCO monitoring system AND:
• \< 18 years old
• Vulnerable patients
• Atrial or ventricular arrhythmia: you need a stable pulse to measure the contour.
• Aortic, mitral or tricuspid valve insufficiency. In the case of valve insufficiency the valve does not close correctly. Therefore, the thermodilution curve is affected by indicator regurgitation, resulting in a prolonged indicator decay time.
• Intra-Aortic Balloon pump: once again, the pulse contour is all wrong; but you can still get thermodilution cardiac output measurements.
• Aortic aneurysm: the contour will be bizarre because the arterial compliance is going to be weird, with the aortic aneurysm acting as a damping system by absorbing all the pressure wave.
• Extracorporeal circuit: when you are on bypass, there is no real arterial waveform
• Pneumonectomy: PiCCO relies on there being a relatively normal pulmonary vasculature.
• Massive pulmonary embolism: as above; it is essentially a pneumonectomy by embolism.
• Intracardiac shunt: the PA catheter will also give an inaccurate thermodilution reading.
• Less than a minimal tidal volume 6-8mL/kg
• NON-positive pressure ventilated patients:
• Why does Stroke Volume Variation only apply to positive pressure ventilated patients? It still applies in spontaneously breathing patients; however it is a poorer predictor of fluid responsiveness.
• Why? The sensitivity is decreased: its only 63%. The spontaneous breathing efforts draw a smaller tidal volume, and from such minor changes in thoracic pressure there would insufficient change in ventricle loading; so there may still be changes to stroke volume, but they would be tiny and difficult to measure.

Sponsors & Collaborators

• King's College Hospital NHS Trust: lead

Study Sites (2)

Lewisham and Greenwhich NHS Trust Foundation

London, SE18, United Kingdom

Location

King´s College Hospital NHS Trust

London, SE5 9RS, United Kingdom

Location

MeSH Terms

Conditions

Acidosis

Condition Hierarchy (Ancestors)

Acid-Base Imbalance; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Month
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 22, 2018
• First Posted: January 18, 2020
• Study Start: May 2, 2018
• Primary Completion: March 31, 2019
• Study Completion: October 31, 2019
• Last Updated: January 18, 2020

Record last verified: 2019-12

Locations

GB (2)