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The Time Used for Determining Optimal CPPNCT03879317

NIRS Directed Optimal Cerebral Perfusion Pressure in Septic Shock Patients: A Feasibility Study

An observational study of The Time Used for Determining Optimal CPP, run by Xiangya Hospital of Central South University.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

After the initial injury, secondary insults including poor cerebral perfusion are main contributors to poor outcome and their early detection and amelioration are keystone to neurocritical care. Read more about this study

Who is it for?
Ages 18 to 90 years
What is being tested?
Continuous NIRS monitoring
Type of treatment
Medical device
How many people
30 participants
Where
No sites listed yet
Study dates
1 Jul 2019to 31 Dec 2019
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 to 90 years
  • All sexes
  • Adult, Older adult

Study population: Adult (age ≥ 18 years) septic shock patients admitted to ICU because of septic shock and predicted to stay in ICU ≥ 24 hours.

Who may be able to join

  • Age ≥ 18 years;
  • Admitted to ICU because of septic shock. The diagnostic criteria of sepsis 3.0 was according to the jointly issued definition by the American Association of Critical Care Medicine and the European Society of Critical Care Medicine.
  • Predicted to stay in ICU ≥ 24 hours

Who cannot join

  • Unable to perform NIRS monitoring because of anatomic factors: such as forehead skin damage, intracranial gas accumulation, severe edema of monitoring sites;
  • Patients with severe organ failure: such as poorly controlled chronic hypertension, chronic renal failure.

About this study

After the initial injury, secondary insults including poor cerebral perfusion are main contributors to poor outcome and their early detection and amelioration are keystone to neurocritical care. Nonetheless, the guidelines for blood pressure management still recommend a single target blood pressure for critically ill patients: the international Guidelines for management of sepsis recommend a MAP of at least 65 mmHg; Some guidelines recognize that patients with a history of hypertension may require a higher MAP. However, these guidelines do not currently recommend cerebral autoregulation-guided therapy and leave many unanswered questions. Cerebral autoregulation is the mechanism that maintains cerebral blood supply, hence CBF approximately constant despite changes in MAP or, more precisely, despite changes in CPP. Maintaining blood pressure within the cerebral blood flow (CBF) autoregulation range (termed "optimal MAP") is associated with improved outcomes for patients. The observational data suggests that management of patients above or below CPPopt 5mmHg is associated with better outcomes and mortality than the other greater variation range.The most commonly used method for monitoring dynamic cerebrovascular reactivity is the pressure reactivity index (PRx) that uses ICP as a surrogate for CBV. However, assessing the PRx requires invasive ICP monitoring which limits its application in many clinical areas. Alternatively, in the absence of invasive intracranial pressure monitoring to determine CPP, a continuous autoregulation monitoring can be accomplished by the continuous correlation between transcranial Doppler (TCD)-measured CBF velocity of the middle cerebral artery and the mean arterial blood pressure (termed mean velocity index or Mx) . Mx is a validated index of cerebral autoregulation based on measures of cerebral perfusion pressure and mean flow velocity on transcranial doppler but is impractical for longer-term monitoring and requires system training, the results are operator-dependent. Near-infrared spectroscopy (NIRS) measurements is another alternative for real-time autoregulation monitoring in the form of a Tissue Oxygenation Index. In contrast to TCD, the NIRS sensors are very easy to apply (the probes attach to the forehead with self-adhesive pads) and do not require frequent calibration making them more suitable for long-term monitoring. Therefore, in this study, Patients in the intervention group will be monitored by continuous NIRS and invasive blood pressure monitoring. The correlation curve between ORI/THx and blood pressure will be obtained through continuous monitoring. According to the correlation curve, the optimal blood pressure which provides the optimal CPP will be determined.

Being tested
Continuous NIRS monitoring

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Continuous NIRS monitoringDevice

    Septic shock patients who have continuous NIRS and blood pressure monitoring at same time will be included. The correlation curve between the brain oxygenation index or the brain hemoglobin index (ORI/THx) and the blood pressure will be obtained. According to the correlation curve, the optimal blood pressure will be determined which provides the optimal CPP.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Optimal CPP

    The minimal time that CPPopt can be determined by the correlation curve between the brain oxygenation index or the brain hemoglobin index (ORI/THx) and the blood pressure

    Measured: 16 hours

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Mar 2019
  2. Study start1 Jul 2019 (estimated)
  3. Primary completion31 Dec 2019 (estimated)
  4. Study completion31 Dec 2019 (estimated)

Resources

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
30 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03879317
Sponsor's protocol ID
2018101082
Status last verified
Oct 2018
First submitted
6 Mar 2019
Last updated
12 Jun 2019
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • Peng Q, Liu X, Ai M, Huang L, Li L, Liu W, Zhao C, Hu C, Zhang L. Cerebral autoregulation-directed optimal blood pressure management reduced the risk of delirium in patients with septic shock. J Intensive Med. 2024 Feb 2;4(3):376-383. doi: 10.1016/j.jointm.2023.12.003. eCollection 2024 Jul.

    PubMed 39035614

Questions about this trial

What is this clinical trial studying?

An observational study of The Time Used for Determining Optimal CPP, run by Xiangya Hospital of Central South University.

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 2 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: status not confirmed, as of the sponsor's last update on 12 Jun 2019. Status can change between updates, so confirm with the study contact before making plans.

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?

Results are not available in the source record.

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?

Optimal CPP (time frame: 16 hours). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03879317, which also lists 1 linked publication.

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 12 Jun 2019.

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