Hydroxyethyl Starch

Overview

Hydroxyethyl starch (HES/HAES) is a nonionic starch derivative. Hydroxyethyl starches (HES) are synthetic colloids commonly used for fluid resuscitation to replace intravascular volume. HES is a general term and can be sub-classified according to average molecular weight, molar substitution, concentration, C2/C6 ratio and Maximum Daily Dose.

Indication

An intravenous solution of hydroxyethyl starch is used to prevent shock following severe blood loss caused by trauma, surgery, or other issues.

Associated Conditions

Hypovolaemia

Clinical Trials

Title	Posted	Study ID	Phase	Status	Sponsor
Safety and Efficacy of Perioperative Volume Replacement with Volulyte 6% in Moderate-to-high Cardiovascular Risk Patients Having Major Abdominal Surgery	2024/10/29	NCT06663254	Phase 4	Not yet recruiting	Xiangya Hospital of Central South University
Comparison of Hydroxyethyl Starch and Crystalloid Coload Combined With Norepinephrine Infusion for Hypotension	2022/07/27	NCT05475990	Not Applicable	Completed	General Hospital of Ningxia Medical University
6% Hydroxyethyl Starch (130/0.4) Coload for Postspinal Anesthesia Hypotension	2022/07/27	NCT05475886	Not Applicable	Recruiting	General Hospital of Ningxia Medical University
Days Alive and Out of Hospital for Patients With Sepsis	2020/09/28	NCT04567433	N/A	Completed	The George Institute for Global Health, Australia
Restrictive or Doppler-guided Fluid Treatment in Colorectal Surgery	2018/09/19	NCT03677622	Not Applicable	Completed	Holbaek Sygehus
Different Preloads for Prevention of Hypotension in Patients Undergoing Elective CS Under Intrathecal Anesthesia	2018/03/15	NCT03465943	Early Phase 1	UNKNOWN	Assiut University
A Comparison of Eleview Versus Hetastarch as Injectate for EMR	2017/11/22	NCT03350217	Phase 4	Completed	Indiana University
Safety and Efficacy of a 6% Hydroxyethyl Starch (HES) Solution Versus an Electrolyte Solution in Trauma Patients	2017/11/09	NCT03338218	Phase 4	Completed	Fresenius Kabi
Comparing Human Albumin Versus Hydroxyethylstarch in Renal Transplant Recipients	2017/10/11	NCT03306914	Not Applicable	Completed	Cairo University
Safety and Efficacy of 6% Hydroxyethyl Starch (HES) Solution Versus an Electrolyte Solution in Patients Undergoing Elective Abdominal Surgery	2017/09/11	NCT03278548	Phase 4	Completed	Fresenius Kabi

FDA Drug Approvals

Approved Product	Manufacturer	NDC Code	Route	Strength	Effective Date
6% HETASTARCH IN 0.9% SODIUM CHLORIDE	HF Acquisition Co LLC, DBA HealthFirst	51662-1317	INTRAVENOUS	6 g in 100 mL	1/29/2024
Hextend	Hospira, Inc.	0409-1555	INTRAVENOUS	6 g in 100 mL	2/15/2023
Hetastarch in Sodium Chloride	Hospira, Inc.	0409-7248	INTRAVENOUS	6 g in 100 mL	7/21/2022

EMA Drug Approvals

Approved Product	Authorization Holder	Status	Issued Date
No EMA approvals found for this drug.

HSA Drug Approvals

Approved Product	Manufacturer	Approval Number	Dosage Form	Strength	Approval Date
VOLUVEN SOLUTION FOR INFUSION 6%	FRESENIUS KABI DEUTSCHLAND GMBH	SIN12297P	INJECTION	60 g/l	5/16/2003

NMPA Drug Approvals

Approved Product	Company	Approval Number	Drug Type	Dosage Form	Approval Date
No NMPA approvals found for this drug.

PPB Drug Approvals

Approved Product	Registration No.	Company	Licence No.	Strength	Registration Date
VOLULYTE 6% SOLUTION FOR INFUSION	N/A	FRESENIUS KABI HONG KONG LIMITED	N/A	N/A	7/20/2009

TGA Drug Approvals

Approved Product	ARTG ID	Sponsor	Registration Type	Status	Registration Date
VOLUVEN 6% hydroxyethyl starch 130/0.4 250 mL solution for intravenous infusion bag	120359	Fresenius Kabi Australia Pty Ltd	Medicine	A	11/13/2006
VOLUVEN 6% hydroxyethyl starch 130/0.4 500 mL solution for intravenous infusion bag	120361	Fresenius Kabi Australia Pty Ltd	Medicine	A	11/13/2006
VOLUVEN 6% hydroxyethyl starch 130/0.4 500 mL solution for intravenous infusion bottle	120358	Fresenius Kabi Australia Pty Ltd	Medicine	A	11/13/2006
VOLULYTE 6%	172173	Fresenius Kabi Australia Pty Ltd	Medicine	A	8/26/2011
VOLUVEN 6% hydroxyethyl starch 130/0.4 250 mL solution for intravenous infusion bottle	120276	Fresenius Kabi Australia Pty Ltd	Medicine	A	11/13/2006
VOLULYTE 6%	187473	Fresenius Kabi Australia Pty Ltd	Medicine	A	8/26/2011

Health Canada Drug Approvals

Approved Product	Company	DIN	Dosage Form	Strength	Market Date
VOLUVEN	fresenius kabi canada ltd	02278057	Solution - Intravenous	6 %	9/18/2006
VOLULYTE	fresenius kabi canada ltd	02357291	Solution - Intravenous	6 %	5/16/2011
HEXTEND	biotime inc	02246024	Solution - Intravenous	6 G / 100 ML	12/11/2003

CIMA AEMPS Drug Approvals

Approved Product	Company	Registration Number	Pharmaceutical Form	Prescription Type	Status
No CIMA AEMPS (Spain) approvals found for this drug.

Philippines FDA Drug Approvals

Approved Product	Company	License Number	Dosage Form	Strength	Approval Date
No Philippines FDA approvals found for this drug.

Saudi SFDA Drug Approvals

Approved Product	Company	License Number	Dosage Form	Strength	Approval Date
No Saudi SFDA approvals found for this drug.

Malaysia NPRA Drug Approvals

Approved Product	Company	Registration Number	Dosage Form	Strength	Approval Date
No Malaysia NPRA approvals found for this drug.

UK EMC Drug Information

Medicine Name	MA Holder	MA Number	Pharmaceutical Form	Active Ingredient	Authorization Date
No UK EMC drug information found for this drug.

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