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

NCT04231045 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 300

Last updated 2020-01-18

No results posted yet for this study

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.

Conditions

  • Acidosis
  • Cardiac; Deficiency
  • Acid Base Disorder

Interventions

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

Sponsors & Collaborators

  • King's College Hospital NHS Trust

    lead OTHER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-05-02
Primary Completion
2019-03-31
Completion
2019-10-31
FDA Device
Yes

Countries

  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04231045 on ClinicalTrials.gov