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| ID | Type | Description | Link |
|---|---|---|---|
| EKBB: EK 244/04 |
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| Name | Class |
|---|---|
| Fresenius AG | INDUSTRY |
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Background: In patients with severe sepsis and septic shock early aggressive volume replacement reduced mortality. Standard infusion therapy consists of crystalloid infusions. The role of modern, low molecular weight, starch preparations and their influence on the course of disease is not determined yet.
Hypothesis: The purpose of this study is to determine wether initial infusion therapy with Hydroxyethylstarch and Ringer's lactate reduces in septic patients reduces Intensive Care Unit and hospital length of stay without impairment of renal function
Design: Double-blind, randomized, controlled monocentric study
Setting: Intensive Care Units of a University Hospital
Patients: 240 consecutive patients with sepsis, severe sepsis and septic shock
Intervention: Volume therapy with Ringer's lactate and saline or hydroxy-ethyl starch (MW 130, substitution 0.4) in the first five days of intensive care treatment.
Parameter:
Statistics: Mann-Whitney test for non-parametric data like intensive care length of stay. Unpaired t-Test for kidney function parameters.
Study withdrawal: Significant impairment of kidney function parameters in the hydroxy-ethyl starch group
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| HES, Septic shock, resuscitation | Active Comparator | study group with HES 6% |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| hydroxy-ethyl starch (MW 130; 0.4) vs. normal saline | Drug | hydroxy-ethyl starch together with ringer's lactate versus physiologic saline together with saline |
|
| Measure | Description | Time Frame |
|---|---|---|
| Intensive Care length of stay | time to discharge from the Intensive care unit | |
| Hospital length of stay | time to discharge from the hospital | |
| Mortality | intesive care, hospital and one year mortality |
| Measure | Description | Time Frame |
|---|---|---|
| Kidney function | at intensive care discharge and after one year | |
| Lung function | during intensive care |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Martin Siegemund, MD | Anaesthesia and Intensive Care, State Hospital, CH-5404 Baden, Switzerland | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Surgical ICU, University Hospital Basel | Basel | 4031 | Switzerland | |||
| Medical ICU, Univesity Hospital Basel |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 11794169 | Background | Rivers E, Nguyen B, Havstad S, Ressler J, Muzzin A, Knoblich B, Peterson E, Tomlanovich M; Early Goal-Directed Therapy Collaborative Group. Early goal-directed therapy in the treatment of severe sepsis and septic shock. N Engl J Med. 2001 Nov 8;345(19):1368-77. doi: 10.1056/NEJMoa010307. | |
| 15542955 | Background |
| Label | URL |
|---|---|
| Link to the homepage of the Department of Anaesthesia and Intensive Care Basel, Switzerland | View source |
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| ID | Term |
|---|---|
| D018805 | Sepsis |
| D012772 | Shock, Septic |
| ID | Term |
|---|---|
| D007239 | Infections |
| D018746 | Systemic Inflammatory Response Syndrome |
| D007249 | Inflammation |
| D010335 | Pathologic Processes |
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| ID | Term |
|---|---|
| C485123 | HES 130-0.4 |
| D000077325 | Ringer's Lactate |
| D012965 | Sodium Chloride |
| ID | Term |
|---|---|
| D000077324 | Crystalloid Solutions |
| D007552 | Isotonic Solutions |
| D012996 | Solutions |
| D004364 | Pharmaceutical Preparations |
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|
| Basel |
| CH-4031 |
| Switzerland |
| Vincent JL, Gerlach H. Fluid resuscitation in severe sepsis and septic shock: an evidence-based review. Crit Care Med. 2004 Nov;32(11 Suppl):S451-4. doi: 10.1097/01.ccm.0000142984.44321.a4. |
| 15163774 | Background | Finfer S, Bellomo R, Boyce N, French J, Myburgh J, Norton R; SAFE Study Investigators. A comparison of albumin and saline for fluid resuscitation in the intensive care unit. N Engl J Med. 2004 May 27;350(22):2247-56. doi: 10.1056/NEJMoa040232. |
| 11289347 | Background | Schortgen F, Lacherade JC, Bruneel F, Cattaneo I, Hemery F, Lemaire F, Brochard L. Effects of hydroxyethylstarch and gelatin on renal function in severe sepsis: a multicentre randomised study. Lancet. 2001 Mar 24;357(9260):911-6. doi: 10.1016/S0140-6736(00)04211-2. |
| 12091178 | Background | De Backer D, Creteur J, Preiser JC, Dubois MJ, Vincent JL. Microvascular blood flow is altered in patients with sepsis. Am J Respir Crit Care Med. 2002 Jul 1;166(1):98-104. doi: 10.1164/rccm.200109-016oc. |
| 12627010 | Background | Dellinger RP. Cardiovascular management of septic shock. Crit Care Med. 2003 Mar;31(3):946-55. doi: 10.1097/01.CCM.0000057403.73299.A6. No abstract available. |
| D013568 |
| Pathological Conditions, Signs and Symptoms |
| D012769 | Shock |
| D002712 |
| Chlorides |
| D006851 | Hydrochloric Acid |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017670 | Sodium Compounds |