Acidosis Clinical Trial
Official title:
The Impact of Systemic pH on Cardiac Function and Clinical Outcome in the Critically Ill Patient
NCT number | NCT04231045 |
Other study ID # | 227870 |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | May 2, 2018 |
Est. completion date | October 31, 2019 |
Verified date | December 2019 |
Source | King's College Hospital NHS Trust |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational [Patient Registry] |
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. Assess whether there are significant changes in cardiac function associated with changes
in blood pH.
2. Relate the changes in cardiac function to the presence or absence of underlying cardiac
disease.
Study Design:
A prospective multicenter observational study in 6 ICU´s (between two Trusts). During a year
study period, a minimum of 300 patients will be recruited.
Status | Completed |
Enrollment | 300 |
Est. completion date | October 31, 2019 |
Est. primary completion date | March 31, 2019 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria (the three criteria): - Inclusion Criteria ALL patients on PiCCO monitoring system - Over 18 years old. - On PiCCO for more than 24 hours Exclusion Criteria: 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. - If there is profound hypovolemia, the IVC can collapse on inspiration. Obviously this decreases preload and confuses your SVV. You cannot predict fluid responsiveness this way, because you never get an accurate impression of preload. - In spontaneous respiration, inspiration increases the right ventricular preload, which means the right ventricular filling is likely still appeared adequate even if there is some hypovolemia. In spite of low overall volume, the right ventricular preload remains adequate, and thus at least one of the ventricles is likely to be operating in the preload-independent straight part of the Frank-Starling curve - Severe obesity: In obese patients, Extravascular Lung Water Index (EVLWI) is underestimated because it is related to body weight. |
Country | Name | City | State |
---|---|---|---|
United Kingdom | King´s College Hospital NHS Trust | London | |
United Kingdom | Lewisham and Greenwhich NHS Trust Foundation | London |
Lead Sponsor | Collaborator |
---|---|
King's College Hospital NHS Trust |
United Kingdom,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | 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. | ITBVI(Intra thoracic blood volume index): 850-1000ml/m2. If not available : ITBVI= GEDI X 1.25 | within 24 hours of being started on the PICCO monitoring system through cardiovascular monitoring study completion, an average of 5 days per patient | |
Other | 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. | GEDI (Global end-diastolic volume index) 680- 800 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 | |
Primary | 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 | |
Primary | 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 | |
Primary | 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 | 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. | GEF (Global ejection fraction): 25- 35% : GEF = (4 x SV) / GEDV. A % of total blood expelled from the heart every beat to the total amount of blood estimated to be present just prior to ventricular systole. | within 24 hours of being started on the PICCO monitoring system through cardiovascular monitoring study completion, an average of 5 days per patient | |
Secondary | 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. | (dPmx) Index of Left Ventricular Contractility. dPmx is a direct measurement of contractility. The dPmx is a measure of how fast the pressure rises during systole. 900-1200 mmHg/s. | within 24 hours of being started on the PICCO monitoring system through cardiovascular monitoring study completion, an average of 5 days per patient | |
Secondary | 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. | CFI (Cardiac function index): 4.5- 6.5 L/min The ratio of the index of cardiac output to the index of the GEDV. A measure of how well the CO is doing in relation to its preload. | within 24 hours of being started on the PICCO monitoring system through cardiovascular monitoring study completion, an average of 5 days per patient | |
Secondary | 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. | CPI (Cardiac Power Index). Represents the power of left ventricular cardiac output in watts. 0.5-0.7 W/m2 | within 24 hours of being started on the PICCO monitoring system through cardiovascular monitoring study completion, an average of 5 days per patient |
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