NCT04231045

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

The Impact of Systemic pH on Cardiac Function and Clinical Outcome in the Critically Ill Patient

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 300 (actual)
• Sponsor: King's College Hospital NHS Trust · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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. 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.

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

Interventions

Type	Name	Description
DEVICE	PiCCO device cardiac monitoring	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

Timeline

• Start date: 2018-05-02
• Primary completion: 2019-03-31
• Completion: 2019-10-31
• First posted: 2020-01-18
• Last updated: 2020-01-18

Locations

2 sites across 1 country: United Kingdom

Regulatory

• FDA-regulated device study