Serial Vasopressin and Copeptin Levels in Children With Sepsis and Septic Shock (VaCoSS)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified October 2011 by KK Women's and Children's Hospital.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
National Medical Research Council (NMRC), Singapore
Information provided by (Responsible Party):
Jan Hau Lee, KK Women's and Children's Hospital
ClinicalTrials.gov Identifier:
NCT00698048
First received: June 12, 2008
Last updated: October 11, 2011
Last verified: October 2011
  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 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 be 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: Observational Model: Cohort
Time Perspective: 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

Blood samples


Estimated Enrollment: 153
Study Start Date: August 2008
Estimated Study Completion Date: December 2011
Estimated Primary Completion Date: December 2011 (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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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@gmail.com   
Principal Investigator: Jan Hau Lee, MRCPCH (UK)         
Sub-Investigator: Janil Puthucheary, MRCP, MRCPCH         
Sub-Investigator: Yoke Hwee Chan, MMed, MRCP         
Sponsors and Collaborators
Jan Hau Lee
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: Jan Hau Lee, Dr Lee Jan Hau, KK Women's and Children's Hospital
ClinicalTrials.gov Identifier: NCT00698048     History of Changes
Other Study ID Numbers: NIG07nov002
Study First Received: June 12, 2008
Last Updated: October 11, 2011
Health Authority: Singapore: Domain Specific Review Boards

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

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

ClinicalTrials.gov processed this record on October 22, 2014