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Cristalloid vs. colloid in patients with severe sepsis and septic shock.


- candidate number1823
- NTR NumberNTR501
- ISRCTNISRCTN25391663
- Date ISRCTN created9-jan-2006
- date ISRCTN requested13-dec-2005
- Date Registered NTR11-nov-2005
- Secondary IDsN/A 
- Public TitleCristalloid vs. colloid in patients with severe sepsis and septic shock.
- Scientific TitleCristalloid versus Colloid resuscitation in patients with severe sepsis or septic shock; effects on extravascular lung water en tissue oxygen tension.
- ACRONYMKRISCOLL (in Dutch: KRIStalloid vs. COLLoid)
- hypothesisTo demonstrate wether there is difference in tissue oxygen tension and extravascular lung water while patients are being resuscitated with cristalloids or colloids combined with cristalloids.
- Healt Condition(s) or Problem(s) studiedSepsis, Septic shock
- Inclusion criteriaSever 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.
- Exclusion criteriaPatients under the age of 18 years and patients with a sensitivity to starch-products.
- mec approval receivedyes
- multicenter trialno
- randomisedyes
- masking/blindingNone
- controlActive
- groupCrossover
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 14-nov-2005
- planned closingdate31-dec-2007
- Target number of participants60
- InterventionsSubjects are assigned to be resuscitated either with cristalloids (sodiumchloride 0,9%) or cristalloid combined with colloids (polyhydroxyethylstarch 10%) untill rescusitation endpoints have been established.
Endpoints are an intrathoracal blood volume of > 850 ml/m2, a mean arterial pressure of > 70 mmHg and a cardiac index of > 3.0 l/min/m2.
- Primary outcomeThe relation between the resuscitation regime and the tissue oxygen tension.
Furthermore the relation between the resuscitation regime and the amount of extravascular lungwater, as well as the relation between the amount of extravascular lungwater and the tissue oxygen tension.
- Secondary outcome1. Subcutaneous temperature;
2. Labaratory findings: hemoglobine, hematrocrite, albumine, arterial and venous bloodgasses;
3. Hemodynamic parameters: cardiac output, VO2, DO2;
4. Respiratory parameters: PEEP, PaO2/FiO2 ratio; inotropes.
- TimepointsN/A
- Trial web siteN/A
- statusinclusion stopped: follow-up
- CONTACT FOR PUBLIC QUERIESProf. Dr. L.P.H. Leenen
- CONTACT for SCIENTIFIC QUERIESDr. R. Braams
- Sponsor/Initiator University Medical Center Utrecht (UMCU)
- Funding
(Source(s) of Monetary or Material Support)
University Medical Center Utrecht (UMCU), Department of Surgery
- PublicationsN/A
- Brief summaryN/A
- Main changes (audit trail)
- RECORD11-nov-2005 - 1-feb-2010


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