Cerebral Pulsatility Index Compared To Mean Arterial Blood Pressure Guided Protocol In Sepsis Induced Encephalopathy:

Sponsor
Tanta University (Other)
Overall Status
Recruiting
CT.gov ID
NCT05842616
Collaborator
(none)
112
1
2
3
37.1

Study Details

Study Description

Brief Summary

The aim of our study is to compare between transcranial doppler pulsatility index and mean arterial blood pressure in guiding management of sepsis induced encephalopathy.

Condition or Disease Intervention/Treatment Phase
  • Other: Transcranial doppler pulsatility index guided protocol
  • Other: Mean arterial blood pressure guided protocol
N/A

Detailed Description

Sepsis induced encephalopathy is the most frequent sepsis related organ dysfunction. It appears early during the course of infection, often before any other organ involvement in up to 70% of hospitalized septic patients and is associated with significant change of cerebral circulation caused by redistribution of blood flow during sepsis that accompanies the abnormal inflammatory response during an infection, in absence of direct central nervous system involvement.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
112 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Norepinephrine Titration In Patients With Sepsis Induced Encephalopathy: Cerebral Pulsatility Index Compared To Mean Arterial Blood Pressure Guided Protocol
Anticipated Study Start Date :
May 1, 2023
Anticipated Primary Completion Date :
Aug 1, 2023
Anticipated Study Completion Date :
Aug 1, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: Transcranial doppler pulsatility index guided protocol

Norepinephrine titration that will be guided by Transcranial doppler (TCD) pulsatility index.

Other: Transcranial doppler pulsatility index guided protocol
Norepinephrine titration that will be guided by Transcranial doppler pulsatility index.

Active Comparator: Mean arterial blood pressure guided protocol

Norepinephrine titration that will be guided by Mean arterial blood pressure (MAP).

Other: Mean arterial blood pressure guided protocol
Norepinephrine titration that will be guided by Mean arterial blood pressure (MAP).

Outcome Measures

Primary Outcome Measures

  1. Intensive care unit (ICU) mortality [28 day or till death which earlier]

    Incidence of Intensive care unit (ICU) stay will be recorded

Secondary Outcome Measures

  1. Mean arterial pressure [24 hours]

    Fluid resuscitation will be started using crystalloids at a rate of 4 to 6 ml/kg with reevaluation after 15 minutes. If MAP is still less than 65 mmhg, fluid resuscitation should be continued at a rate of 4 to 6 ml/kg with reevaluation after another 15 minutes up to 30 ml/kg. Vasopressors will be started if the patient is still hypotensive during or after resuscitation without delay even peripherally to avoid delay until central venous access is secured (norepinephrine is the first line agent preferred over other vasopressors).

  2. Norepinephrine titration [24 hours]

    Fluid resuscitation will be started using crystalloids at a rate of 4 to 6 ml/kg with reevaluation after 15 minutes. If MAP is still less than 65 mmhg, fluid resuscitation should be continued at a rate of 4 to 6 ml/kg with reevaluation after another 15 minutes up to 30 ml/kg. Vasopressors will be started if the patient is still hypotensive during or after resuscitation without delay even peripherally to avoid delay until central venous access is secured (norepinephrine is the first line agent preferred over other vasopressors).

  3. Cerebral perfusion pressure [24 hours]

    Cerebral perfusion pressure (CPP) will be done using transcranial doppler.

  4. Outcome of encephalopathy [28 day]

    Encephalopathy outcome at ICU discharge using Glasgow coma scale (GCS)

  5. SOFA score [Up to 4 weeks.]

    SOFA score at ICU admission and discharge.

  6. Length of ICU stay [At least 28 days]

    Length of ICU stay

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  • Patients aged 18 years or older

  • Must had clinical diagnosis of sepsis induced encephalopathy.

Exclusion Criteria:
  • Refusal to participate in the study.

  • Cerebral infection.

  • Known cerebral lesions (Neoplasm, Traumatic brain injury, Stroke, Ischemic or hemorrhagic cerebrovascular lesions, high intracranial pressure).

  • Known severe carotid stenosis (>70%).

  • Intoxication due to drugs.

  • Pregnancy.

  • Patients supported by intra-aortic balloon pumb (IABP).

Contacts and Locations

Locations

Site City State Country Postal Code
1 Tanta University Hospitals Tanta Elgharbia Egypt 31527

Sponsors and Collaborators

  • Tanta University

Investigators

  • Principal Investigator: Mai S Aboshaara, MD, Assistant lecturer

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Mai Salah Salem, Assistant lecturer, Tanta University
ClinicalTrials.gov Identifier:
NCT05842616
Other Study ID Numbers:
  • 35559/6/22
First Posted:
May 6, 2023
Last Update Posted:
May 6, 2023
Last Verified:
May 1, 2023
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of May 6, 2023