Condition category
Infections and Infestations
Date applied
09/01/2006
Date assigned
09/01/2006
Last edited
07/04/2006
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Prof L.P.H. Leenen

ORCID ID

Contact details

University Medical Centre Utrecht
Department of Surgery HP G04.228
P.O. Box 85500
Utrecht
3584 CX
Netherlands
+31 (0)30 2509882
lleenen@chir.azu.nl

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Acronym

KRISCOLL (in Dutch: KRIStalloid versus COLLoid)

Study hypothesis

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

Not provided at time of registration

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Not Specified

Patient information sheet

Condition

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

Phase

Not Specified

Drug names

Primary outcome measures

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 trial start date

14/11/2005

Overall trial end date

31/12/2007

Reason abandoned

Eligibility

Participant 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.

Participant type

Patient

Age group

Adult

Gender

Not Specified

Target number of participants

60

Participant exclusion criteria

Patients under the age of 18 years and patients with a sensitivity to starch-products.

Recruitment start date

14/11/2005

Recruitment end date

31/12/2007

Locations

Countries of recruitment

Netherlands

Trial participating centre

University Medical Centre Utrecht
Utrecht
3584 CX
Netherlands

Sponsor information

Organisation

University Medical Center Utrecht (The Netherlands)

Sponsor details

P.O. Box 85500
Utrecht
3508 GA
Netherlands

Sponsor type

Not defined

Website

Funders

Funder type

University/education

Funder name

University Medical Centre Utrecht, Department of Surgery

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes