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Cerebrovascular Effects of the Use of Alpha-stat or pH-stat Management of Cardiopulmonary Bypass

NCT03816280 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 200

Last updated 2019-05-16

No results posted yet for this study

Summary

Type 2 diabetes mellitus (T2DM) poses a significant burden on the patients and the health care system. The increasing number of surgery performed in elderly population results in an increased number of perioperative T2DM-related adverse effects. T2DM has a prevalence of 30-40% in a population undergoing cardiovascular surgery. Cardiac surgery, especially cardiopulmonary bypass (CPB) is also known to deteriorate cerebral oxygenation.

Furthermore, acid-base balance of patients undergoing CPB can be managed using two main regimes: alpha-stat and pH-stat. The use of pH-stat acid-base management involves maintaining the patient's temperature-corrected pH at a constant level (7.40) and maintaining normocapnia (pCO2 of 40 mmHg). Alpha-stat acid-base management on the other hand is performed by maintaining the ionization state of histidine by keeping the pH stable when a standardized temperature of 37C is used. Therefore, while a constant pH (7.40) and normocapnia (pCO2 of 40 mmHg) are targeted when measured at 37C, the hypothermia applied during CPB will result in a lower pCO2 and in a relative respiratory alkalosis. Previous studies investigating alpha-stat and pH-stat managements demonstrated increased jugular venous oxygen concentrations when pH-stat management was applied.

Therefore, our study is aimed at characterizing the effects of an alpha-stat or pH-stat acid-base management regime on the cerebral oxygenation, parameters of regional cerebral oxygen supply and demand during and following CPB in diabetic patients. These parameters include regional cerebral tissue oxygen saturation (rSO2), central venous oxygen saturation ScvO2) and the physiological saturation gap between ScvO2 and rSO2 (gSO2).

Conditions

Interventions

PROCEDURE

Elective cardiopulmonary bypass (CPB)

All groups undergo elective cardiopulmonary bypass (CPB)

PROCEDURE

Alpha-stat acid-base management

Acid-base status during CPB will be maintained using the alpha-stat regime

PROCEDURE

pH-stat acid-base management

Acid-base status during CPB will be maintained using the pH-stat regime

Sponsors & Collaborators

  • GINOP

    collaborator UNKNOWN

  • Hungarian Basic Research Council

    collaborator OTHER

  • Szeged University

    lead OTHER

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-02-01
Primary Completion
2020-07-31
Completion
2020-07-31

Countries

  • Hungary

Study Locations

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Entities

Diseases

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 NCT03816280 on ClinicalTrials.gov