AcidosisNCT04231045
The Impact of the pH on Cardiac Function in the Critically Ill Patient
An observational study of Acidosis and Cardiac; Deficiency, run by King's College Hospital NHS Trust at 2 sites in United Kingdom.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acidosis, Cardiac; Deficiency, Acid Base Disorder
- What is being tested?
- PiCCO device cardiac monitoring
- Type of treatment
- Medical device
- How many people
- 300 participants
- Where
- 2 sitesUnited Kingdom
- Study dates
- 2 May 2018to 31 Oct 2019
- How long will I take part?
- 1 Month
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: UK NHS (National Health service) patients admitted to ICU over 18 years old
Who may be able to join
- Inclusion Criteria ALL patients on PiCCO monitoring system
- Over 18 years old.
- On PiCCO for more than 24 hours
Who cannot join
- 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.
Show all 18Show fewer
- 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.
Trial locations and contacts
2 sites in 1 country.
United Kingdom2 sites
Lewisham and Greenwhich NHS Trust Foundation
London, SE18
King´s College Hospital NHS Trust
London, SE5 9RS
About this study
Official title: The Impact of Systemic pH on Cardiac Function and Clinical Outcome in the Critically Ill Patient
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:
Read more
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:
- Assess whether there are significant changes in cardiac function associated with changes in blood pH.
- 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.
Read the detailed description
Aim The aim of this study is to test the hypothesis that a change in the acidity of the blood (pH) will affect cardiac function in critically ill patients. It will also explore if the presence or absence of underlying cardiac disease and the type of pH abnormality may affect the response of the heart to changes in pH.
Justification for design Blood pH and cardiac function are monitored routinely in critically ill patients and so a prospective observational study design would be a feasible and useful method to address this question.
Inclusion/exclusion criteria explanation In intensive care practice, if a patient requires close cardiac function monitoring clinicians will use a special system for continuously monitoring the cardiac output and other heart functions to guide therapy. The system most commonly used is called PiCCO (pulse contour cardiac output).
Adult patients who are on PiCCO as part of their routine care in ICU for more than 24 hours will be eligible for inclusion in the study.
All patients who do not already have PiCCO in situ will be excluded from the study.
Identification of patients The direct care team will identify all eligible patients in the participating Units. The investigators have agreed to conduct the study in 6 different intensive care units across 2 Trusts and 4 sites - King's College Hospital Foundation Trust - including 3 ICU's at Denmark Hill site and 1 at Princess Royal University Hospital site; Lewisham and Greenwich NHS Trust - including ICU at University Hospital Lewisham and Queen Elizabeth Hospital, Woolwich.
Justification for sample size
In order to examine the relationship between a change in pH and cardiac contractility with power 80% and a 95% confidence interval, it has been calculated that it will be necessary to analyse 363 cases. Statistical analysis will be based on a retrospective audit of the numbers of a patient who fit the criteria, the investigators have assessed that across the 7 units the target sample size will be easily achieved in less than 1 year.
Data collection Data will be collected from ICU charts, medical notes and electronic patient records. This data is routinely collected as part of standard hospital care. The data will be collected by the direct care team and anonymised before it is transferred securely to a statistician for statistical analysis. The patient will not undergo any additional assessments or tests.
Consent All the data to be analysed is routinely collected as part of standard hospital care. There will be no additional tests or assessments in relation to this study. All data will be anonymised prior to analysis therefore, the investigators request approval to enrol patients without obtaining consent.
Data handling A case report form will be completed for each participant. Each participant will be given a unique study identification number. The patient's hospital number will be recorded on the case report form, and data will be collected by the direct care team. When data collection is completed at day 30, the direct care team will remove the top section of the case report form so that the hospital number is removed.
An enrolment log will be stored in the Site File securely on-site in a locked cupboard.
The data will be analysed according to the statistical plan. Results will be published in a peer-review journal.
- Conditions
- Acidosis, Cardiac; Deficiency, Acid Base Disorder
- Being tested
- PiCCO device cardiac monitoring
- Keywords
- acidosis, cardiac contractility, acid-base disorder
- Medical subject headings
- Acidosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PiCCO device cardiac monitoringDevice
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
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: PiCCO device cardiac monitoring |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 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
Measured: 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
Measured: 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.
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.
Measured: 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.
(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.
Measured: 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.
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.
Measured: 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.
CPI (Cardiac Power Index). Represents the power of left ventricular cardiac output in watts. 0.5-0.7 W/m2
Measured: within 24 hours of being started on the PICCO monitoring system through cardiovascular monitoring study completion, an average of 5 days per patient
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jan 2020
- Study start2 May 2018
- Primary completion31 Mar 2019
- Study completion31 Oct 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AcidosisStudies of the same condition, open and under way.
- More trials run by King's College Hospital NHS TrustThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 300 participants (actual)
- Target duration
- 1 Month
Sponsor and investigators
- Lead sponsor
- King's College Hospital NHS Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04231045
- Sponsor's protocol ID
- 227870
- Status last verified
- Dec 2019
- First submitted
- 22 Jun 2018
- Last updated
- 18 Jan 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 18 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Systemic pH on Cardiac Function and Clinical Outcome in the Critically Ill Patient
- ClinicalTrials.gov ID
- NCT04231045
- Acronym / sponsor ID
- 227870
- Conditions
- Acidosis, Cardiac; Deficiency, Acid Base Disorder
- Keywords
- acidosis, cardiac contractility, acid-base disorder
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 300 participants (actual)
- Lead sponsor
- King's College Hospital NHS TrustUniversity, hospital or other
- Study start
- 2 May 2018 (actual)
- Primary completion
- 31 Mar 2019 (actual)
- Study completion
- 31 Oct 2019 (actual)
- First posted
- 18 Jan 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Assess whether there are significant changes in cardiac function associated with changes in blood pH.
- 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.
Detailed description
Aim The aim of this study is to test the hypothesis that a change in the acidity of the blood (pH) will affect cardiac function in critically ill patients. It will also explore if the presence or absence of underlying cardiac disease and the type of pH abnormality may affect the response of the heart to changes in pH.
Justification for design Blood pH and cardiac function are monitored routinely in critically ill patients and so a prospective observational study design would be a feasible and useful method to address this question.
Inclusion/exclusion criteria explanation In intensive care practice, if a patient requires close cardiac function monitoring clinicians will use a special system for continuously monitoring the cardiac output and other heart functions to guide therapy. The system most commonly used is called PiCCO (pulse contour cardiac output).
Adult patients who are on PiCCO as part of their routine care in ICU for more than 24 hours will be eligible for inclusion in the study.
All patients who do not already have PiCCO in situ will be excluded from the study.
Identification of patients The direct care team will identify all eligible patients in the participating Units. The investigators have agreed to conduct the study in 6 different intensive care units across 2 Trusts and 4 sites - King's College Hospital Foundation Trust - including 3 ICU's at Denmark Hill site and 1 at Princess Royal University Hospital site; Lewisham and Greenwich NHS Trust - including ICU at University Hospital Lewisham and Queen Elizabeth Hospital, Woolwich.
Justification for sample size
In order to examine the relationship between a change in pH and cardiac contractility with power 80% and a 95% confidence interval, it has been calculated that it will be necessary to analyse 363 cases. Statistical analysis will be based on a retrospective audit of the numbers of a patient who fit the criteria, the investigators have assessed that across the 7 units the target sample size will be easily achieved in less than 1 year.
Data collection Data will be collected from ICU charts, medical notes and electronic patient records. This data is routinely collected as part of standard hospital care. The data will be collected by the direct care team and anonymised before it is transferred securely to a statistician for statistical analysis. The patient will not undergo any additional assessments or tests.
Consent All the data to be analysed is routinely collected as part of standard hospital care. There will be no additional tests or assessments in relation to this study. All data will be anonymised prior to analysis therefore, the investigators request approval to enrol patients without obtaining consent.
Data handling A case report form will be completed for each participant. Each participant will be given a unique study identification number. The patient's hospital number will be recorded on the case report form, and data will be collected by the direct care team. When data collection is completed at day 30, the direct care team will remove the top section of the case report form so that the hospital number is removed.
An enrolment log will be stored in the Site File securely on-site in a locked cupboard.
The data will be analysed according to the statistical plan. Results will be published in a peer-review journal.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Month
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients on PiCCO monitoring system | – | Device: PiCCO device cardiac monitoringALL 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- UK NHS (National Health service) patients admitted to ICU over 18 years old
Key inclusion criteria (3 listed)
- Inclusion Criteria ALL patients on PiCCO monitoring system
- Over 18 years old.
- On PiCCO for more than 24 hours
Key exclusion criteria (18 listed)
- < 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PiCCO device cardiac monitoringPiCCO 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 | Device | Patients on PiCCO monitoring system |
Primary outcome
Assess whether there are significant changes in stroke volume index associated with changes in blood pH using PiCCO technology monitoring.
Time frame: within 24 hours of being started on the PICCO monitoring system through cardiovascular monitoring study completion, an average of 5 days per patient
SVI- Stroke Volumen Index (40-60 mL/ m2)
Assess whether there are significant changes in CI -Cardiac index or PCCI are associated with changes in blood pH using PiCCO technology monitoring.
Time frame: within 24 hours of being started on the PICCO monitoring system through cardiovascular monitoring study completion, an average of 5 days per patient
CI (Cardiac index or PCCI): 3-5 L/min/m2
Assess whether there are significant changes in CO-Cardiac Output or PCCO are associated with changes in blood pH using PiCCO technology monitoring.
Time frame: within 24 hours of being started on the PICCO monitoring system through cardiovascular monitoring study completion, an average of 5 days per patient
CO (Cardiac Output or PCCO): 4 - 8 L/min
4 secondary outcomes
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: within 24 hours of being started on the PICCO monitoring system through cardiovascular monitoring study completion, an average of 5 days per patient
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jan 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Acidosis and Cardiac; Deficiency, run by King's College Hospital NHS Trust at 2 sites in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assess whether there are significant changes in stroke volume index associated with changes in blood pH using PiCCO technology monitoring. (time frame: within 24 hours of being started on the PICCO monitoring system through cardiovascular monitoring study completion, an average of 5 days per patient). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jan 2020.