Cristalloid versus colloid in patients with severe sepsis and septic shock
| ISRCTN | ISRCTN25391663 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN25391663 |
| Secondary identifying numbers | N/A |
- Submission date
- 09/01/2006
- Registration date
- 09/01/2006
- Last edited
- 07/04/2006
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Infections and Infestations
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
Plain English summary of protocol
Not provided at time of registration
Contact information
Prof L.P.H. Leenen
Scientific
Scientific
University Medical Centre Utrecht
Department of Surgery HP G04.228
P.O. Box 85500
Utrecht
3584 CX
Netherlands
| Phone | +31 (0)30 2509882 |
|---|---|
| lleenen@chir.azu.nl |
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Not specified |
| Study type | Not Specified |
| Scientific title | |
| Study acronym | KRISCOLL (in Dutch: KRIStalloid versus COLLoid) |
| Study objectives | To demonstrate whether there is difference in tissue oxygen tension and extravascular lung water while patients are being resuscitated with cristalloids or colloids combined with cristalloids. |
| Ethics approval(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | Sepsis, Septic shock |
| Intervention | Subjects are assigned to be resuscitated either with cristalloids (sodium chloride 0.9%) or cristalloid combined with colloids (polyhydroxyethylstarch 10%) until resuscitation endpoints have been established. Endpoints are an intrathoracal blood volume of >850 ml/m^2, a mean arterial pressure of >70 mmHg and a cardiac index of >3.0 l/min/m^2. |
| Intervention type | Other |
| Primary outcome measure | The relation between the resuscitation regime and the tissue oxygen tension. Furthermore the relation between the resuscitation regime and the amount of extravascular lung water, as well as the relation between the amount of extravascular lung water and the tissue oxygen tension. |
| Secondary outcome measures | 1. Subcutaneous temperature 2. Laboratory findings: hemoglobin, hematrocrite, albumin, arterial and venous blood gasses 3. Hemodynamic parameters: cardiac output, VO2, DO2 4. Respiratory parameters: PEEP, PaO2/FiO2 ratio; inotropes |
| Overall study start date | 14/11/2005 |
| Completion date | 31/12/2007 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Not Specified |
| Target number of participants | 60 |
| Key inclusion criteria | Sever sepsis or septic shock (according to the criteria of the American College of Chest Physicians/Society of Critical Care Medicine) in a mechanically ventilated ICU patient. |
| Key exclusion criteria | Patients under the age of 18 years and patients with a sensitivity to starch-products. |
| Date of first enrolment | 14/11/2005 |
| Date of final enrolment | 31/12/2007 |
Locations
Countries of recruitment
- Netherlands
Study participating centre
University Medical Centre Utrecht
Utrecht
3584 CX
Netherlands
3584 CX
Netherlands
Sponsor information
University Medical Center Utrecht (The Netherlands)
Not defined
Not defined
P.O. Box 85500
Utrecht
3508 GA
Netherlands
"ROR" |
https://ror.org/0575yy874 |
|---|
Funders
Funder type
University/education
University Medical Centre Utrecht, Department of Surgery
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
