Cerebrovascular Autoregulation in Sepsis, Influence of Renal Replacement Therapy

NCT01926301 | Withdrawn

• 1 other identifier: 83743712
• Study Type: observational
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

The cerebrovascular autoregulation is impaired in patients with severe sepsis and septic shock. A continuous veno-venous hemodialysis may improve impaired cerebrovascular autoregulation. Hypothesis: continuous hemodialysis recovers impaired cerebrovascular autoregulation in patients with acute severe sepsis and septic shock.

Conditions

Severe Sepsis; Septic Shock

Keywords

sepsis; cerebrovascular autoregulation; delirium

Outcome Measures

Primary Outcomes (1)

• Cerebrovascular autoregulation

  Cerebrovascular autoregulation measured daily at the first 4 days of severe sepsis and septic shock

  during the first 4 days

Secondary Outcomes (1)

• Delirium

  at day 4

Study Arms (2)

Hemodialysis

Patients with severe sepsis or septic shock with acute renal failure and requirement of continuous veno-venous hemodialysis

Procedure: continuous veno-venous hemodialysis

No hemodialysis

Patients with severe sepsis or septic shock without acute renal failure and no requirement of continuous veno-venous hemodialysis

Interventions

continuous veno-venous hemodialysis PROCEDURE

Also known as: Renal replacement therapy

Hemodialysis

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients with severe sepsis or septic shock at the intensive care unit of an university general hospital

You may qualify if:

• severe sepsis or septic shock
• adult patients
• possibility of transcranial Doppler ultrasound

You may not qualify if:

• traumatic brain injury
• known cerebrovascular diseases
• Infection of the brain
• chronic renal failure
• pregnancy

Sponsors & Collaborators

• Johannes Gutenberg University Mainz: lead

Study Sites (1)

University Medical Center of the Johannes Gutenberg-Univerity

Mainz, 55131, Germany

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Serum and whole blood

MeSH Terms

Conditions

Sepsis; Shock, Septic; Delirium

Interventions

Continuous Renal Replacement Therapy; Renal Replacement Therapy

Condition Hierarchy (Ancestors)

Infections; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Shock; Confusion; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Neurocognitive Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Therapeutics; Extracorporeal Circulation; Surgical Procedures, Operative

Study Officials

• Patrick Schramm, MD

  Johannes Gutenberg University Mainz

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: August 17, 2013
• First Posted: August 20, 2013
• Study Start: August 1, 2013
• Primary Completion: June 1, 2020
• Study Completion: June 1, 2020
• Last Updated: June 11, 2020

Record last verified: 2020-06

Locations

DE (1)