Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Best priming for cardiopulmonary bypass in cardiac surgery is unknown. Efficacy and toxicity of Hydroxyethyl Starch 130/0.4 used in this context are uncertain.
The aim of this pilot study is to determine if Hydroxyethyl Starch 130/0.4 is more effective than Sodium Chloride 0.9% in short term hemodynamic purpose without side renal or hemostatic effect.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Hydroxyethyl starch 130/0.4 | Experimental |
| |
| Sodium Chloride 0.9% | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Non balanced Hydroxyethyl starch 130/0.4 (Voluven®, Fresenius) | Drug | 1000mL used for cardiopulmonary bypass priming |
|
| Measure | Description | Time Frame |
|---|---|---|
| Supplementary volume of fluid administered during cardiopulmonary bypass (ml) | Fluid administered during cardiopulmonary bypass for normal functioning, with the exception of blood product, cardioplegia and priming | Day 1 (From initiation to separation of cardiopulmonary bypass) |
| Measure | Description | Time Frame |
|---|---|---|
| Variation of preoperative hematocrit and lowest hematocrit during cardiopulmonary bypass | Continuous monitoring of hematocrit during cardiopulmonary bypass. | Day 1 (From initiation to separation of cardiopulmonary bypass) |
| Fluid balance |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospices Civils de Lyon - Hopital Louis Pradel | Bron | 69500 | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31138465 | Result | Schweizer R, Lameche M, Coelembier C, Portran P, Fornier W, Colombet B, Grinberg D, Pozzi M, Jacquet-Lagreze M, Fellahi JL. Cardiopulmonary Bypass Priming with Hydroxyethyl Starch 6% 130/0.4 or Sodium Chloride 0.9%: A Preliminary Double-Blind Randomized Controlled Study in Cardiac Surgery. J Cardiothorac Vasc Anesth. 2019 Dec;33(12):3534-3535. doi: 10.1053/j.jvca.2019.05.003. Epub 2019 May 10. No abstract available. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Sodium Chloride 0.9% (Fresenius) | Drug | 1000mL used for cardiopulmonary bypass priming |
|
Difference between total intraoperative volume of fluids administered (vascular filling, blood products, cardioplegia, priming) and total intraoperative volume of fluids loss (urine, bleedings)
| Hour 0 |
| Fluid balance | Difference between total intraoperative volume of fluids administered (vascular filling, blood products, cardioplegia, priming) and total intraoperative volume of fluids loss (urine, bleedings) | Hour 12 |
| Sequential Organ Failure Assessment score | Hour 24 |
| Sequential Organ Failure Assessment score | Hour 0 |
| Acid-Base parameters : arterial pH | Hour 24 |
| Acid-Base parameters : Base Excess | Hour 0 |
| Acid-Base parameters : Base Excess | H24 |
| Acid-Base parameters : Lactatemia | Hour 0 |
| Acid-Base parameters : Lactatemia | Hour 24 |
| Acid-Base parameters : Chloremia | Hour 0 |
| Acid-Base parameters : Chloremia | Hour 24 |
| Coagulation parameters : platelets | Hour 0 |
| Coagulation parameters : prothrombin | Hour 0 |
| Coagulation parameters : activated partial thromboplastin | Hour 0 |
| Coagulation parameters : fibrinogen level | Hour 0 |
| Coagulation parameters : platelets | H24 |
| Coagulation parameters : prothrombin | H24 |
| Coagulation parameters : activated partial thromboplastin | H24 |
| Coagulation parameters : fibrinogen level | H24 |
| Hemoglobin level | Hour 0 |
| Hemoglobin level | Hour 24 |
| Surgical bleeding | Hour 12 |
| Surgical bleeding | during surgical drainage, an average of 24 hours |
| Revision surgery for bleeding | Hour 12 |
| Delay for ablation of surgical drainage | Day of ablation of surgical drainage, 24 hours |
| Antiemetic medication use | Any antiemetic medication used during this period | end of intensive care unit stay, 24 hours |
| Delay to first extubation (number of hours) | Hour of first extubation, an average of 5 hours |
| Intensive care unit stay (number oh days) | Day of intensive care unit stay exit |
| Hospital stay (number of days) | Day of hospital exit, an average of 7 days |
| Creatinine level variation | Day 5 |
| Creatinine level variation | Day 28 |
| Creatinine level variation | Day 90 |
| Renal replacement therapy use during intensive care stay | end of intensive care unit stay, an average of 24 hours |
| Renal replacement therapy dependency | Day 28 |
| Renal replacement therapy dependency | Day 90 |
| Mortality of any cause | During hospital stay, an average of 7 days |
| Mortality of any cause | Day 28 |
| Mortality of any cause | Day 90 |
| ID | Term |
|---|---|
| C485123 | HES 130-0.4 |
| D012965 | Sodium Chloride |
| ID | Term |
|---|---|
| D002712 | Chlorides |
| D006851 | Hydrochloric Acid |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017670 | Sodium Compounds |
Not provided
Not provided