Clinical Trials Logo

Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05842616
Other study ID # 35559/6/22
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date May 1, 2023
Est. completion date September 1, 2024

Study information

Verified date April 2024
Source Tanta University
Contact Mai S Aboshaara, MD
Phone +201061107658
Email dr_mai.s.salem91@hotmail.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 112
Est. completion date September 1, 2024
Est. primary completion date September 1, 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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).

Study Design


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
Egypt Tanta University Hospitals Tanta Elgharbia

Sponsors (1)

Lead Sponsor Collaborator
Tanta University

Country where clinical trial is conducted

Egypt, 

Outcome

Type Measure Description Time frame Safety issue
Primary Intensive care unit (ICU) mortality Incidence of Intensive care unit (ICU) stay will be recorded 28 day or till death which earlier
Secondary Mean arterial pressure 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).
24 hours
Secondary Norepinephrine titration 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).
24 hours
Secondary Cerebral perfusion pressure Cerebral perfusion pressure (CPP) will be done using transcranial doppler. 24 hours
Secondary Outcome of encephalopathy Encephalopathy outcome at ICU discharge using Glasgow coma scale (GCS) 28 day
Secondary SOFA score SOFA score at ICU admission and discharge. Up to 4 weeks.
Secondary Length of ICU stay Length of ICU stay At least 28 days
See also
  Status Clinical Trial Phase
Active, not recruiting NCT05095324 - The Biomarker Prediction Model of Septic Risk in Infected Patients
Completed NCT02714595 - Study of Cefiderocol (S-649266) or Best Available Therapy for the Treatment of Severe Infections Caused by Carbapenem-resistant Gram-negative Pathogens Phase 3
Completed NCT03644030 - Phase Angle, Lean Body Mass Index and Tissue Edema and Immediate Outcome of Cardiac Surgery Patients
Completed NCT02867267 - The Efficacy and Safety of Ta1 for Sepsis Phase 3
Completed NCT04804306 - Sepsis Post Market Clinical Utility Simple Endpoint Study - HUMC
Recruiting NCT05578196 - Fecal Microbial Transplantation in Critically Ill Patients With Severe Infections. N/A
Terminated NCT04117568 - The Role of Emergency Neutrophils and Glycans in Postoperative and Septic Patients
Completed NCT03550794 - Thiamine as a Renal Protective Agent in Septic Shock Phase 2
Completed NCT04332861 - Evaluation of Infection in Obstructing Urolithiasis
Completed NCT04227652 - Control of Fever in Septic Patients N/A
Enrolling by invitation NCT05052203 - Researching the Effects of Sepsis on Quality Of Life, Vitality, Epigenome and Gene Expression During RecoverY From Sepsis
Terminated NCT03335124 - The Effect of Vitamin C, Thiamine and Hydrocortisone on Clinical Course and Outcome in Patients With Severe Sepsis and Septic Shock Phase 4
Recruiting NCT04005001 - Machine Learning Sepsis Alert Notification Using Clinical Data Phase 2
Completed NCT03258684 - Hydrocortisone, Vitamin C, and Thiamine for the Treatment of Sepsis and Septic Shock N/A
Recruiting NCT05217836 - Iron Metabolism Disorders in Patients With Sepsis or Septic Shock.
Completed NCT05018546 - Safety and Efficacy of Different Irrigation System in Retrograde Intrarenal Surgery N/A
Completed NCT03295825 - Heparin Binding Protein in Early Sepsis Diagnosis N/A
Not yet recruiting NCT06045130 - PUFAs in Preterm Infants
Not yet recruiting NCT05361135 - 18-fluorodeoxyglucose Positron Emission Tomography/Computed Tomography in S. Aureus Bacteraemia N/A
Not yet recruiting NCT05443854 - Impact of Aminoglycosides-based Antibiotics Combination and Protective Isolation on Outcomes in Critically-ill Neutropenic Patients With Sepsis: (Combination-Lock01) Phase 3