Use of PiCCO System in Critically Ill Patients With Septic Shock and Acute Respiratory Distress Syndrome

NCT01526382 | Completed Phase 1

• 1 other identifier: ZZH-01
• Study Type: interventional
• Target: 350
• Locations: 1 country
• Sites: 2

Brief Summary

PiCCO has been widely used in critical care settings for several decades. Together with pulmonary artery catheter, it is regarded as the important tool for guiding fluid management in patients with shock or acute respiratory distress syndrome. However, its effects on patients' outcome remain untested. The investigators study is a pilot study that is designed to test whether the use of PiCCO will improve patients' outcome, as compared to those without PiCCO monitoring.

Conditions

Septic Shock; Acute Respiratory Distress Syndrome

Keywords

septic shock; acute respiratory distress syndrome; transpulmonary thermodilution technique; mortality

Outcome Measures

Primary Outcomes (1)

• 30 day mortality

  death from any cause before day 30

  30 days

Secondary Outcomes (6)

• 14 day mortality

  14 days

• ICU length of stay

  up to 30 days

• days on mechanical ventilation

  up to 30 days

• days of vasoactive agents support

  up to 30 days

• ICU free survival days during 30-day period

  30 days

Study Arms (2)

intervention arm

ACTIVE COMPARATOR

patients allocated to intervention arm receive PiCCO monitoring for hemodynamics and pulmonary conditions

Device: PiCCO monitoring (PULSION)

control arm

PLACEBO COMPARATOR

Patients in this arm do not receive PiCCO monitoring device to guide fluid management, but central venous catheter can be inserted at the discretion of treating physician.

Procedure: central venous catheter

Interventions

PiCCO monitoring (PULSION) DEVICE

Patients are monitored with PiCCO system.

Also known as: PiCCO (pulsion medical system, PULSION PiCCO plus)

intervention arm

central venous catheter PROCEDURE

patients in this arm can receive central venous catheter

control arm

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients were included if they were diagnosed with Shock, Acute respiratory distress syndrome (ARDS), or both.
• Shock was defined by the presence 4 criteria:
• Heart rate of at least 90/min;
• A respiratory rate of at least 20/min or a PaCO2 of 32mmHg or lower or the use of mechanical ventilation;
• The use of vasopressors to maintain a systolic blood pressure of at least 90mmHg despite fluid resuscitation, low dose of dopamine (≤ 5 μg/kg per minute), or dobutamine;
• at least 1 of 3 signs of hypoperfusion (urine output \< 0.5mL/kg of body weight per hour for 1 hour or more; neurologic dysfunction defined by confusion, psychosis, or a Glasgow coma scale score of ≤ 6; plasma lactate higher than the upper limit of the normal value).
• Acute respiratory distress syndrome：
• the presence of acute decrease in PaO2/FIO2 to 200mmHg or lower,
• bilateral pulmonary infiltrates or a chest radiograph consistent with edema;
• no clinical evidence of left atrial hypertension; and requirement for positive pressure ventilation.

You may not qualify if:

• Patients were moribund.
• signed do-not-resuscitation odor.

Sponsors & Collaborators

• Jinhua Central Hospital: lead

Study Sites (2)

department of critical care medicine, Jinhua central hospital

Jinhua, Zhejiang, 321000, China

Location

Traditional Chinese Medical hospital of Jinhua City

Jinhua, Zhejiang, 321000, China

Location

Related Publications (2)

• Richard C, Warszawski J, Anguel N, Deye N, Combes A, Barnoud D, Boulain T, Lefort Y, Fartoukh M, Baud F, Boyer A, Brochard L, Teboul JL; French Pulmonary Artery Catheter Study Group. Early use of the pulmonary artery catheter and outcomes in patients with shock and acute respiratory distress syndrome: a randomized controlled trial. JAMA. 2003 Nov 26;290(20):2713-20. doi: 10.1001/jama.290.20.2713.

  PMID: 14645314 BACKGROUND

• Zhang Z, Xu X, Yao M, Chen H, Ni H, Fan H. Use of the PiCCO system in critically ill patients with septic shock and acute respiratory distress syndrome: a study protocol for a randomized controlled trial. Trials. 2013 Feb 1;14:32. doi: 10.1186/1745-6215-14-32.

  PMID: 23374652 DERIVED

MeSH Terms

Conditions

Shock, Septic; Respiratory Distress Syndrome

Interventions

Central Venous Catheters

Condition Hierarchy (Ancestors)

Sepsis; Infections; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Shock; Lung Diseases; Respiratory Tract Diseases; Respiration Disorders

Intervention Hierarchy (Ancestors)

Vascular Access Devices; Catheters; Equipment and Supplies

Study Officials

• Zhongheng Zhang, MD

  Jinhua Municipal Central Hospital

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: principal investigator

Study Record Dates

• First Submitted: January 27, 2012
• First Posted: February 3, 2012
• Study Start: January 1, 2012
• Primary Completion: June 1, 2014
• Study Completion: June 1, 2014
• Last Updated: May 4, 2015

Record last verified: 2012-09

Locations

CN (2)