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Serial Vasopressin and Copeptin Levels in Children With Sepsis and Septic Shock (VaCoSS)
This study is currently recruiting participants.
Verified by KK Women's and Children's Hospital, June 2008
First Received: June 12, 2008   Last Updated: September 23, 2008   History of Changes
Sponsors and Collaborators: KK Women's and Children's Hospital
National Medical Research Council (NMRC), Singapore
Information provided by: KK Women's and Children's Hospital
ClinicalTrials.gov Identifier: NCT00698048
  Purpose

Patients with severe infection can develop very low blood pressure. There are many mechanisms leading to this,and one of them appears to involve a hormone called vasopressin. In children as compared to adults, the mechanism and response to low blood pressure are different for reasons that are not clear. One possibility is the difference in the production and/or response to vasopressin. Vasopressin has been become part of the treatment of children with low blood pressure in the setting of severe infection, when other treatment has failed, but its use is on the basis of animal and adult studies. The exact timing and dose is uncertain. In this research study, the patients will receive standard treatment for sepsis and septic shock, and the investigators will measure the blood levels of vasopressin and a related compound called copeptin (both are required to understand the mechanism of control involved). Blood will need to taken from patients without any sepsis so as to be able to compare the values in health and in sickness. The patient groups the investigators have chosen for this are those children who will have blood taken anyway as part of their routine care. The aim of this study is to develop an understanding of the body's hormonal response (with respect to vasopressin) to severe infection in children. The long-term aim is to improve the care of critically ill children with severe infection by using the most appropriate dose of vasopressin at the most appropriate time.


Condition
Sepsis
Septic Shock

Study Type: Observational
Study Design: Cohort, Prospective
Official Title: Serial Vasopressin and Copeptin Levels in Children With Sepsis and Septic Shock

Resource links provided by NLM:


Further study details as provided by KK Women's and Children's Hospital:

Primary Outcome Measures:
  • Vasopressin and copeptin levels [ Time Frame: First 5 days of admission ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples With DNA

Biospecimen Description:

Blood samples


Estimated Enrollment: 105
Study Start Date: August 2008
Estimated Study Completion Date: August 2010
Estimated Primary Completion Date: August 2010 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   up to 16 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Children between one day of age and sixteen years old.

Criteria

Inclusion Criteria:

Control Group:

  • Neonates admitted for neonatal jaundice requiring phototherapy
  • Previously well patients admitted for elective gastrointestinal endoscopy, patients admitted for non-specific abdominal pain and
  • Pre-operative patients for circumcision, inguinal hernias and chronic orthopaedic conditions

Study Group:

  • The investigators will also enroll children with sepsis and septic shock
  • Sepsis will be defined as proposed by the International pediatric sepsis consensus conference.
  • Children will be recruited into the septic shock group if they have sepsis and features of cardiovascular organ dysfunction as defined by the same consensus conference.

Exclusion Criteria:

  • Neonates weighing less than 2.5 kg
  • Neonates less than 36 weeks gestation
  • Children more than 16 years of age
  • Patients with a history of congenital heart disease
  • Patients with chronic renal impairment
  • Patients with chronic liver impairment
  • Patients on active chemotherapy
  • Patients on chronic mineralocorticoids or glucocorticoids therapy
  • Patients on long-term diuretic therapy
  • Patients with central nervous system tumours
  • Patients with developmental delay
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00698048

Locations
Singapore
KK Women's and Children's Hospital Recruiting
Singapore, Singapore, 229899
Contact: Jan Hau Lee, MBBS, MRCPCH         leejanhau@hotmail.com    
Principal Investigator: Jan Hau Lee, MRCPCH (UK)            
Sub-Investigator: Janil Puthucheary, MRCP, MRCPCH            
Sub-Investigator: Yoke Hwee Chan, MMed, MRCP            
Sponsors and Collaborators
KK Women's and Children's Hospital
National Medical Research Council (NMRC), Singapore
Investigators
Principal Investigator: Jan Hau Lee, MRCPCH(UK) KK Women's and Children's Hospital
  More Information

No publications provided

Responsible Party: KK Women's and Children's Hospital ( Dr. Lee Jan Hau )
Study ID Numbers: NIG07nov002
Study First Received: June 12, 2008
Last Updated: September 23, 2008
ClinicalTrials.gov Identifier: NCT00698048     History of Changes
Health Authority: Singapore: Institutional Review Board

Keywords provided by KK Women's and Children's Hospital:
Sepsis
Septic Shock
Vasopressin
Copeptin
Paediatrics

Study placed in the following topic categories:
Arginine Vasopressin
Systemic Inflammatory Response Syndrome
Sepsis
Shock
Arginine
Shock, Septic
Vasoconstrictor Agents
Vasopressins
Cardiovascular Agents
Hemostatics
Inflammation

Additional relevant MeSH terms:
Systemic Inflammatory Response Syndrome
Coagulants
Physiological Effects of Drugs
Hematologic Agents
Cardiovascular Agents
Infection
Pharmacologic Actions
Hemostatics
Inflammation
Arginine Vasopressin
Sepsis
Pathologic Processes
Shock
Natriuretic Agents
Therapeutic Uses
Shock, Septic
Vasoconstrictor Agents
Vasopressins
Antidiuretic Agents

ClinicalTrials.gov processed this record on August 28, 2009