Serial Vasopressin and Copeptin Levels in Children With Sepsis and Septic Shock (VaCoSS)
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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 |
- 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 |
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| 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 | |
| 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:
|
Sepsis Toxemia Shock Shock, Septic Infection Systemic Inflammatory Response Syndrome Inflammation Pathologic Processes Vasopressins Arginine Vasopressin |
Hemostatics Coagulants Hematologic Agents Therapeutic Uses Pharmacologic Actions Vasoconstrictor Agents Cardiovascular Agents Antidiuretic Agents Natriuretic Agents Physiological Effects of Drugs |
ClinicalTrials.gov processed this record on May 16, 2013