Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| EudraCT no.:2007-006065-32 |
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
The aim of the study is to evaluate the efficacy of Voluven® in the prevention of maternal hypotension in women undergoing spinal anesthesia for cesarean section
Intravenous fluid administration prior to spinal anesthesia for cesarean section is an established part of anesthetic practice for the prevention of maternal hypotension. Systematic reviews of clinical data suggest the usefulness of administering colloids to decrease the incidence of hypotension This study will compare the clinical efficacy and safety of HES 130/0.4 (6%) in normal saline vs. Ringer's lactate solution in prevention of hypotension during spinal anesthesia for elective cesarean section.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group A | Experimental | 500 mL of HES 130/0.4 (6%) and 500 mL Ringer's Lactate Solution |
|
| Group B | Active Comparator | 1000 mL Ringer's Lactate solution |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HES 130/0.4 (6%) in sodium chloride (solution for infusion) | Drug | 500 mL of HES 130/0.4 (6%) and 500 mL Ringer's Lactate Solution |
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of hypotension | Time between induction of spinal anesthesia until delivery |
| Measure | Description | Time Frame |
|---|---|---|
| Minimum of systolic blood pressure until delivery | between induction of anesthesia and delivery | |
| Maternal heart rate between induction of anesthesia and delivery | between induction of anesthesia and delivery |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Frederic Mercier, Professor | Hôpital Béclère, Service Anesthésie-Réanimation, 157 Rue de la Porte de Trivaux, 92140 Clamart, France | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHU Clermont Ferrand - Hotel Dieu, Service Anesthesie-Reanimation | Clermont-Ferrand | 63003 | France | |||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32619039 | Derived | Chooi C, Cox JJ, Lumb RS, Middleton P, Chemali M, Emmett RS, Simmons SW, Cyna AM. Techniques for preventing hypotension during spinal anaesthesia for caesarean section. Cochrane Database Syst Rev. 2020 Jul 1;7(7):CD002251. doi: 10.1002/14651858.CD002251.pub4. | |
| 24970272 | Derived | Mercier FJ, Diemunsch P, Ducloy-Bouthors AS, Mignon A, Fischler M, Malinovsky JM, Bolandard F, Aya AG, Raucoules-Aime M, Chassard D, Keita H, Rigouzzo A, Le Gouez A; CAESAR Working Group. 6% Hydroxyethyl starch (130/0.4) vs Ringer's lactate preloading before spinal anaesthesia for Caesarean delivery: the randomized, double-blind, multicentre CAESAR trial. Br J Anaesth. 2014 Sep;113(3):459-67. doi: 10.1093/bja/aeu103. Epub 2014 Jun 26. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Ringer's Lactate solution | Drug | 1000 mL Ringer's Lactate solution |
|
|
| Onset and duration of hypotension between induction of anesthesia and delivery | between induction of anesthesia and delivery |
| Phenylephrine requirements to keep systolic blood pressure equal or higher than 95% of baseline value | between induction of anesthesia and delivery |
| Höpital Louis-Mourier - Service d'Anesthesie |
| Colombes |
| 92701 |
| France |
| Département d'Anesthésie-Réanimation - Centre Hospitalo-Universitaire de Bicêtre | Le Kremlin-Bicêtre | 94275 | France |
| Hopital Jeanne de Flandre, CHU | Lille | 59037 | France |
| CHU Hotel Dieu, Service Anesthesie | Lyon | 69002 | France |
| Hopital Arnaud de Villeneuve - Service Anesthésie-Réanimation | Montpellier | 34295 | France |
| Hopital de l'Archet, Service Anesthesie-Reanimation | Nice | 6200 | France |
| Hopital Caremeau, CHU, Service Anesthesie | Nîmes | 30000 | France |
| Hopital Cochin, Service Anesthesie-Reanimation Chirurgicale | Paris | 75014 | France |
| Hôpital Armand-Trousseau, Service d'anesthésie-réanimation | Paris | 75571 | France |
| Hopital Robert Debre, CHU, Service Anesthesie | Reims | 51100 | France |
| Hopital Hautepierre, CHU, Service Reanimation Chirurgicale | Strasbourg | 6700 | France |
| Hopital Foch,Service Anesthesie | Suresnes | 92150 | France |
| Unité d'anesthésie - Maternité Paule de Viguier | Toulouse | 31059 | France |
| ID | Term |
|---|---|
| D007022 | Hypotension |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D006895 | Hydroxyethyl Starch Derivatives |
| D012965 | Sodium Chloride |
| D012996 | Solutions |
| C485123 | HES 130-0.4 |
| D000077325 | Ringer's Lactate |
| ID | Term |
|---|---|
| D013213 | Starch |
| D004040 | Dietary Carbohydrates |
| D002241 | Carbohydrates |
| D005936 | Glucans |
| D011134 | Polysaccharides |
| D002712 | Chlorides |
| D006851 | Hydrochloric Acid |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017670 | Sodium Compounds |
| D004364 | Pharmaceutical Preparations |
| D000077324 | Crystalloid Solutions |
| D007552 | Isotonic Solutions |
Not provided
Not provided