This site became the new on June 19th. Learn more.
Show more Menu IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more... Menu IMPORTANT: Talk with a trusted healthcare professional before volunteering for a study. Read more... Menu
Give us feedback

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

This study has been completed.
National Medical Research Council (NMRC), Singapore
Information provided by (Responsible Party):
Jan Hau Lee, KK Women's and Children's Hospital Identifier:
First received: June 12, 2008
Last updated: September 7, 2015
Last verified: September 2015

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.

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 Jan Hau Lee, KK Women's and Children's Hospital:

Primary Outcome Measures:
  • Vasopressin and copeptin levels [ Time Frame: First 5 days of admission ]

Biospecimen Retention:   Samples With DNA
Blood samples

Enrollment: 136
Study Start Date: August 2008
Study Completion Date: December 2011
Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Septic Shock


Ages Eligible for Study:   up to 16 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Children between one day of age and sixteen years old.

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 identifier: NCT00698048

KK Women's and Children's Hospital
Singapore, Singapore, 229899
Sponsors and Collaborators
Jan Hau Lee
National Medical Research Council (NMRC), Singapore
Principal Investigator: Jan Hau Lee, MRCPCH(UK) KK Women's and Children's Hospital
  More Information

Responsible Party: Jan Hau Lee, Dr Lee Jan Hau, KK Women's and Children's Hospital Identifier: NCT00698048     History of Changes
Other Study ID Numbers: NIG07nov002
Study First Received: June 12, 2008
Last Updated: September 7, 2015

Keywords provided by Jan Hau Lee, KK Women's and Children's Hospital:
Septic Shock

Additional relevant MeSH terms:
Shock, Septic
Diabetes Insipidus
Systemic Inflammatory Response Syndrome
Pathologic Processes
Kidney Diseases
Urologic Diseases
Pituitary Diseases
Endocrine System Diseases
Arginine Vasopressin
Vasoconstrictor Agents
Antidiuretic Agents
Natriuretic Agents
Physiological Effects of Drugs processed this record on September 19, 2017