Delving into the Latest Updates on Hydroxyethyl Starch with Synapse

Overview

Basic Info

Drug Type

Small molecule drug

Synonyms

hydroxyethyl starch, 羟乙基淀粉130/0.4氯化钠注射液, Bolben infusion 6%

+ [7]

Target-

Mechanism-

Therapeutic Areas

Infectious DiseasesOther Diseases

Active Indication-

Inactive Indication

HypovolemiaMassive hemorrhageShock, Septic

Originator Organization

Fresenius Kabi AG

Active Organization

Fresenius Kabi AGFresenius Kabi Deutschland GmbH

Inactive Organization

Novo Nordisk A/S

B. Braun Melsungen AGFresenius Kabi Japan KK

Drug Highest PhaseApproved

First Approval Date

DE (25 Apr 2000)

Regulation-

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The investigators propose a multicenter randomized trial to test the renal safety of 6% hydroxyethyl starch (HES) 130/0.4 combined with sodium acetate Ringer's crystalloid solution in moderate-to-high cardiovascular risk patients having major abdominal surgery. The reference group will only be given sodium acetate Ringer's crystalloid.

Start Date30 Nov 2024

Sponsor / Collaborator

Xiangya Hospital Central South University

CTRI/2024/10/075715 / Not yet recruitingPhase 4IIT

Pretreatment with 6% Hydroxyethyl starch for reduction of propofol injection pain : A prospective randomized controlled study - NIL

Start Date19 Nov 2024

Sponsor / Collaborator-

NCT06664320 / Not yet recruitingNot ApplicableIIT

Impact of Mild Acute Normovolemic Hemodilution on Pre-bypass Coagulation Function During Cardiac Surgery

The impact of acute normovolemic hemodilution (ANH) using hydroxyethyl starch before initiating cardiopulmonary bypass (CPB) on whole blood viscoelastic profile after CPB has not been well established. Patients undergoing cardiac surgery employing moderate hypothermic CPB are randomly allocated into one of two groups: in Group-ANH, ANH is applied by using a balanced hydroxyethyl starch (HES 130/0.6); and in Group-C, ANH is not applied. After weaning from CPB, intergroup differences of INTEM, EXTEM, FIBTEM, and APTEM profiles are analyzed. As a primary outcome, the inter-group differences between maximal clot firmness of EXTEM will be determined at 10 min after ANH in Group-ANH and that at control.

Start Date28 Oct 2024

Sponsor / Collaborator

Konkuk University Medical Center

100 Clinical Results associated with Hydroxyethyl Starch

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100 Translational Medicine associated with Hydroxyethyl Starch

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100 Patents (Medical) associated with Hydroxyethyl Starch

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1,907

Literatures (Medical) associated with Hydroxyethyl Starch

31 Dec 2024·Artificial Cells, Nanomedicine, and Biotechnology

Carbon monoxide polyhemoglobin improves the therapeutic effect and relieves inflammation in the colon tissue of haemorrhagic shock/resuscitation rats

Article

Author: Hao, Shasha ; Xie, Xintong ; Li, Shen ; Liu, Jiaxin ; Zhou, Wentao ; Zhang, Honghui ; Yang, Chengmin ; Wang, Hong ; Wang, Huan

OBJECTIVEThe objective of this study was to test the therapeutic effect of carbon monoxide polyhemoglobin (polyCOHb) in haemorrhagic shock/resuscitation and its underlying mechanisms.METHODS48 rats were divided into two experimental parts, and 36 rats in the first experiment and 12 rats in the second experiment. In the first experimental part, 36 animals were randomly assigned to the following groups: hydroxyethyl starch group (HES group, n = 12), polyhemoglobin group (polyHb group, n = 12), and carbon monoxide polyhemoglobin group (polyCOHb group, n = 12). In the second experimental part, 12 animals were randomly assigned to the following groups: polyHb group (n = 6), and polyCOHb group (n = 6). Then the anaesthetised rats were haemorrhaged by withdrawing 50% of the animal's blood volume (BV), and resuscitated to the same volume of the animal's withdrawing BV with HES, polyHb, polyCOHb. In the first experimental part, the 72h survival rates of each groups animals were measured. In the second experimental part, the rats' mean arterial pressure (MAP), heart rate (HR), blood gas levels and other indicators were dynamically monitored in baseline, haemorrhagic shock (HS), at 0point resuscitation (RS 0h) and after 1 h resuscitation (RS 1h). The concentrations of malondialdehyde (MDA), superoxide dismutase (SOD), tumour necrosis factor-alpha (TNF-alpha) and interleukin-6 (IL-6) were measured by ELISA kits in both groups of rats at RS 1h. Changes in pathological sections were examined by haematoxylin-eosin (HE) staining. Nuclear factor erythroid 2-related factor 2 (Nrf2) and haem oxygenase-1 (HO-1) levels were detected by immunohistochemical analysis, while myeloperoxidase (MPO) levels were detected by immunofluorescence. DHE staining was used to determine reactive oxygen species (ROS) levels.RESULTSThe 72h survival rates of the polyHb and polyCOHb groups were 50.00% (6/12) and 58.33% (7/12) respectively, which were significantly higher than that of the 8.33% (1/12) in the HES group (p < 0.05). At RS 0h and RS 1h, the HbCO content of rats in the polyCOHb group (1.90 ± 0.21, 0.80 ± 0.21) g/L were higher than those in the polyHb group (0.40 ± 0.09, 0.50 ± 0.12)g/L (p < 0.05); At RS 1h, the MDA (41.47 ± 3.89 vs 34.17 ± 3.87 nmol/ml) in the plasma, Nrf2 and HO-1 content in the colon of rats in the polyCOHb group were lower than the polyHb group. And the SOD in the plasma (605.01 ± 24.46 vs 678.64 ± 36.37) U/mg and colon (115.72 ± 21.17 vs 156.70 ± 21.34) U/mg and the MPO content in the colon in the polyCOHb group were higher than the polyHb group (p < 0.05).CONCLUSIONSIn these haemorrhagic shock/resuscitation models, both polyCOHb and polyHb show similar therapeutic effects, and polyCOHb has more effective effects in maintaining MAP, correcting acidosis, reducing inflammatory responses than that in polyHb.

01 Dec 2024·International Journal of Biological Macromolecules

Anti-inflammatory dressing based on hyaluronic acid and hydroxyethyl starch for wound healing

Article

Author: Liu, Yuanqi ; Gao, Yuanyuan ; Chen, Wenyu ; Wei, Kun

Eliminating persistent inflammation and choosing dressings that provide the best healing environment is key to promoting wound healing. Dynamic and reversible hydrogels have attracted much attention because of their capacity to adapt to irregular wound surfaces. Herein, oxidized hydroxyethyl starch (OHES) and hyaluronic acid (HA-ADH) were crosslinked via the dynamic acylhydrazone bond to form an anti-inflammatory function hydrogel (HA-ADH/OHES@XT) that could release xanthatin (XT) slowly. The HA-ADH/OHES hydrogels showed an appropriate gelation time, notable water-retaining capacity, self-healing, suitable biodegradability, and good biocompatibility for wound healing applications. In vivo experiments demonstrated that HA-ADH/OHES@XT hydrogels promoted tissue regeneration and wound healing at a rate of approximately 89.1 % on day 20 by reducing inflammation, increasing collagen deposition, and promoting re-epithelialization, indicating their great potential as a wound dressing.

01 Oct 2024·Journal of Cardiothoracic and Vascular Anesthesia

Epidemiology and Triggers of Severe Perioperative Anaphylaxis: An 8-Year Single-Center Study

Article

Author: Chen, Cuihua ; Chen, Qiuying ; Chen, Yanhua ; Zhou, Lifang ; Xie, Yubo ; Jiang, Yage

OBJECTIVETo determine the features, rescue measures, outcomes, re-allergic reactions, and independent risk factors associated with severe anaphylaxis during surgery.DESIGNInstances of severe perioperative anaphylaxis were identified through perioperative electronic records, adverse event reporting records, and surveys of anesthesiologists. Confirmed cases were randomly matched 4:1 with control cases on the same operation day. Patient risk factors, surgery type, anesthetic technique, and perioperative medications, fluids, and blood transfusions were given in instances of severe perioperative anaphylaxis were compared with control cases.SETTINGA tertiary hospital in China.PATIENTSAll patients undergoing surgery and anesthesia in the operating room from January 2014 to February 2022.MEASUREMENTSIncidence and the independent risk factors for severe perioperative anaphylaxis.MAIN RESULTSNinety-seven patients experienced severe perioperative allergic responses during the 266,033 surgeries performed, with an incidence rate of 3.6 per 10,000. Three of 97 anaphylaxis patients experienced a severe allergic reaction again during the second surgery. The nested case-control study revealed that the independent triggers during surgery were allergy history (odds ratio 5.23; 95% confidence interval [CI], 2.35-11.68; p < 0.001), cisatracurium use (odds ratio 5.03; 95% CI, 1.22-20.70; p < 0.001), hydroxyethyl starch 130/0.4 use (odds ratio 5.36; 95% CI, 2.99-9.60; p =0.025), and allogeneic plasma (odds ratio 11.02; 95% CI, 3.78-35.95; p < 0.001).CONCLUSIONSPerioperative severe anaphylaxis is a rare but life-threatening complication. Previous allergic history, cisatracurium, hydroxyethyl starch 130/0.4, and allogeneic plasma may be the independent triggers. Early diagnosis of anaphylaxis and the timely administration of epinephrine are critical to allergic treatment. Avoiding exposure to allergens is effective for preventing severe allergic responses and the efficacy of glucocorticoids and antihistamines is controversial.

100 Deals associated with Hydroxyethyl Starch

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External Link

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R&D Status

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Massive hemorrhage	Phase 2	JP	Fresenius Kabi Japan KK	01 May 2010
Hypovolemia	Phase 2	JP	Fresenius Kabi Japan KK	01 Nov 2009
Shock, Septic	Phase 2	DE	Novo Nordisk A/S	01 Apr 2003
Shock, Septic	Phase 2	DE	B. Braun Melsungen AG	01 Apr 2003

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Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT02192502 (SHARP, CTgov)	Phase 3	-	149	HES 130/0.4 (Voluven) (HES 130/0.4 (Voluven))	ncyprftdai(jdcwbbnfvl) = dipibbyqxb ngdwellzao (xrishorbvx, iwqdualanj - uozqlilzjd) View more	-	14 Feb 2023
				human albumin 5% (Human Albumin 5%)	ncyprftdai(jdcwbbnfvl) = ijivyweewb ngdwellzao (xrishorbvx, cfsjwcuvuy - pbtnwtjqkl) View more
NCT02726620 (CTgov)	Not Applicable	Hypotension	22,435	Central neuraxial anesthesia+Glycopyrrolate+dopamine+Hydroxyethyl starch solutions+Epinephrine+desflurane+bupivacaine+Sodium Chloride 0.9%+propofol+atropine+Ephedrine+Isoflurane+Dobutamine+Vasopressin+Isoproterenol+norepinephrine+Prilocaine+Benzocaine+Procaine+Terlipressin+Tetracaine+ropivacaine+Articaine+levobupivacaine+Milrinone+phenylephrine+Sevoflurane+Mepivacaine+lidocaine+Chloroprocaine (Usual Care Group)	mawizyunti(utndbinxzx) = gpwnzkqqoa wpyhiextkl (bxvchiwumv, kyztsvyjce - hpnbtewxir) View more	-	16 May 2019
				Central neuraxial anesthesia+Glycopyrrolate+dopamine+Hydroxyethyl starch solutions+Epinephrine+desflurane+bupivacaine+Sodium Chloride 0.9%+propofol+atropine+Ephedrine+Isoflurane+Dobutamine+Vasopressin+Isoproterenol+norepinephrine+Prilocaine+Benzocaine+Procaine+Terlipressin+Tetracaine+ropivacaine+Articaine+levobupivacaine+Milrinone+phenylephrine+Sevoflurane+Mepivacaine+lidocaine+Chloroprocaine (Hypotension Decision Support)	mawizyunti(utndbinxzx) = aauboysrpe wpyhiextkl (bxvchiwumv, pibdlvwrfn - rfxihlsgil) View more
NCT02329158 (Pubmed \| Can J Anaesth)	Not Applicable	-	2,000	hydroxyethyl starch (Patients who did not receive HES)	(hxjbrmflrx): hazard ratio = 1.24 (95% CI, 1.14 - 1.35) View more	-	01 Jan 2019
				hydroxyethyl starch (Patients exposed to HES)
NCT00935168 (CHEST, Pubmed \| Lancet Respir Med)	Phase 3	-	7,000	Hydroxyethyl starch	(rcvzacijkc) = rvuarbjtsa usllwwobms (kyxpeecmlv )	-	01 Oct 2016
				Saline	(rcvzacijkc) = yfwcnvseyo usllwwobms (kyxpeecmlv )
NCT01486563 (Pubmed \| Anesth Analg)	Phase 4	-	40	6% Hydroxyethyl Starch 130/0.4	(rieofozdbq) = ihuoepycjc sbupmhqtix (iliznpzdkd )	-	01 Mar 2015
				Saline 0.9%	(rieofozdbq) = pwkljtynxh sbupmhqtix (iliznpzdkd )
NCT00962156 (Pubmed \| Intensive Care Med)	Phase 3	Sepsis	804	Hydroxyethyl starch 130/0.42	(cjgbslbgdc) = cvmwapwzdh qqepdoqteu (qcwtinxulh ) View more	-	01 Jul 2014
				Ringer's acetate	(cjgbslbgdc) = efmpyeoiyu qqepdoqteu (qcwtinxulh ) View more
NCT00935168 (CHEST, Pubmed \| Br Dent J)	Phase 3	-	7,000	6% HES with a molecular weight of 130 kD and a molar substitution ratio of 0.4 (130/0.4, Voluven) in 0.9% sodium chloride	wpovfqxiig(fhlbkklagw) = xhuiaqoizv svgczoubzj (njfosrftsc ) View more	-	15 Nov 2012
				0.9% sodium chloride (saline)	wpovfqxiig(fhlbkklagw) = jfpajsjjhn svgczoubzj (njfosrftsc ) View more
NCT00962156 (6S, Pubmed \| Br Dent J)	Phase 3	Sepsis	804	Hydroxyethyl starch 130/0.42	znuerieffy(synhohleka) = whzugksmng cadwycbxoq (xuaguikggj ) View more	Negative	12 Jul 2012
				Ringer's acetate	znuerieffy(synhohleka) = jgyynvgyvl cadwycbxoq (xuaguikggj ) View more
NCT00799916 (Pubmed \| J Crit Care)	Phase 3	Sepsis	20	6% hydroxyethyl starch 130/0.4	fsljrotmpg(ycinouzxru) = hfgrpkcvsv bgmoevfcve (ituxugxfbf ) View more	Positive	01 Dec 2010
				Saline solution	fsljrotmpg(ycinouzxru) = dpgrdqldne bgmoevfcve (ituxugxfbf ) View more