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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00698048
Recruitment Status : Completed
First Posted : June 16, 2008
Last Update Posted : September 9, 2015
National Medical Research Council (NMRC), Singapore
Information provided by (Responsible Party):
Jan Hau Lee, KK Women's and Children's Hospital

Brief Summary:

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 or disease
Sepsis Septic Shock

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Study Type : Observational
Actual Enrollment : 136 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Serial Vasopressin and Copeptin Levels in Children With Sepsis and Septic Shock
Study Start Date : August 2008
Actual Primary Completion Date : December 2011
Actual Study Completion Date : December 2011

Resource links provided by the National Library of Medicine

Drug Information available for: Vasopressin

Septic Shock

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

Biospecimen Retention:   Samples With DNA
Blood samples

Information from the National Library of Medicine

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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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00698048

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KK Women's and Children's Hospital
Singapore, Singapore, 229899
Sponsors and Collaborators
Jan Hau Lee
National Medical Research Council (NMRC), Singapore
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Principal Investigator: Jan Hau Lee, MRCPCH(UK) KK Women's and Children's Hospital
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Responsible Party: Jan Hau Lee, Dr Lee Jan Hau, KK Women's and Children's Hospital Identifier: NCT00698048    
Other Study ID Numbers: NIG07nov002
First Posted: June 16, 2008    Key Record Dates
Last Update Posted: September 9, 2015
Last Verified: September 2015
Keywords provided by Jan Hau Lee, KK Women's and Children's Hospital:
Septic Shock
Additional relevant MeSH terms:
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Shock, Septic
Diabetes Insipidus
Systemic Inflammatory Response Syndrome
Pathologic Processes
Kidney Diseases
Urologic Diseases
Pituitary Diseases
Endocrine System Diseases