Voluven

[IveGotTwins]

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Did anyone see this?

http://pulmccm.org/2012/randomized-...ries-kidneys-in-another-large-trial-rct-nejm/

Voluven is pretty popular among some of the staff at my place.

Is this something everyone else already knew because of the revelation of Boldt's gross misrepresentation of his data regarding colloids?

Crystalloid vs. Colloid. The never ending debate.

 

[Idiopathic]

Did anyone see this?

http://pulmccm.org/2012/randomized-...ries-kidneys-in-another-large-trial-rct-nejm/

Voluven is pretty popular among some of the staff at my place.

Is this something everyone else already knew because of the revelation of Boldt's gross misrepresentation of his data regarding colloids?

Crystalloid vs. Colloid. The never ending debate.

thats a very forgiving way to write forgery. ive been avoiding synthetic colloids for a few years now, most of my colleagues are doing so as well. the possibility of worsening renal dysfunction is definitely a consideration.

so, in short, big news, but not surprising. the debate will never be over, at least as it pertains to the large scale, but smaller segments of the population may definitely benefit from careful selection of crystalloid or colloid

 

[BLADEMDA]

Did anyone see this?

http://pulmccm.org/2012/randomized-...ries-kidneys-in-another-large-trial-rct-nejm/

Voluven is pretty popular among some of the staff at my place.

Is this something everyone else already knew because of the revelation of Boldt's gross misrepresentation of his data regarding colloids?

Crystalloid vs. Colloid. The never ending debate.

I still use these colloids in a limited way. On non septic patents or others with no renal insuff/chronic kidney disease I use up to 500 mls.

I recognize the possibility of renal injury with the use of these volume expanders but IMHO, their limited use in the standard operating room patient poses no additional risk to patients. That said, due to possible affects on coagulation issues I limit the amount to 500 mls

 

[BLADEMDA]

Interact Cardiovasc Thorac Surg. 2011 Jun;12(6):1022-7. doi: 10.1510/icvts.2010.263939. Epub 2011 Mar 11.
In cardiac surgery patients does Voluven(R) impair coagulation less than other colloids?
Raja SG, Akhtar S, Shahbaz Y, Masood A.
Source
Department of Cardiac Surgery, Harefield Hospital, Harefield, London UB9 6JH, UK. [email protected]
Abstract
Hydroxyethyl starch (HES) solutions are commonly used for volume replacement in cardiac surgery patients. The degree of impairment of the haemostatic system depends on the molecular weight and substitution degree of HES solutions. It is claimed that as HES 130/0.4 (Voluven(®)) exhibits a lower in vitro molecular weight and a lower degree of hydroxyethyl substitution than HES 200/0.5 (HAES-steril(®)) therefore it has less impact on haemostasis. A best evidence topic in cardiac surgery was written according to a structured protocol to verify this statement. The question addressed was: in cardiac surgery patients does volume replacement with Voluven(®) impair coagulation less than other colloids? Using the reported search 12 papers, three in vitro and nine clinical studies, were found to represent the best evidence to answer the clinical question. The nine clinical studies were all randomised controlled trials. The authors, journal, date and country of publication, patient group studied, study type, relevant outcomes and results of these papers are tabulated. The in vitro studies suggest that HES 130/0.4 has no significant effect on platelet variables, shows a faster clot formation process and a better clot retraction as compared with the other HES solutions. On the other hand, current best available evidence (level 1b) from clinical studies, limited by heterogeneity predominantly in terms of dosage of HES 130/0.4 administered and the sample size of individual trials, overwhelmingly suggests that HES 130/0.4 compared with HES 200/0.5 or gelatin-based volume replacement fluid affects coagulation to the same extent resulting in similar degree of blood loss. It can be concluded that contrary to in vitro studies HES 130/0.4 in clinical practice has comparable effects on blood loss after cardiac surgery.

 

[BLADEMDA]

New Study Results from Use of Hextend®, BioTime, Inc. (Amex: BTIM) 0 comments
Feb 5, 2010 2:40 PM
Results emanated from an independent study evaluating the use of Hextend® in hemodynamically unstable trauma patients. Hextend (6% Hetastarch in Lactated Electrolyte Injection) is BTIM's commercially-available blood plasma volume expander used to treat hypovolemia (low blood volume). The study reported that initial resuscitation with Hextend was associated with NO obvious coagulopathy and reduced mortality compared to fluid resuscitation without Hextend. However, study principals cautioned that their "…study design has several limitations, but that the results are encouraging and warrant a randomized controlled clinical trial". Results showed that overall mortality for the patients treated with Hextend was significantly lower at 5.2 % compared to 8.9 % for the patients receiving fluid resuscitation without Hextend. NO other study has evaluated the safety and efficacy specifically in trauma patients even though there had been several other studies in various other types of surgical patients.

Hextend is a formulation of 6% hetastarch combined with a physiologically balanced crystalloid carrier that more closely mirrors plasma electrolyte balance than 6% hetastarch in 0.9% sodium chloride.

The hetastarch component creates oncotic pressure, which would normally be provided by blood proteins and permits retention of intravascular fluid,
The crystalloid carrier provides electrolytes necessary for physiologic functions and has a composition resembling that of the principal ionic constituents of normal plasma,
Hextend contains a normal physiological level of calcium.
The non-randomized observational trial was the largest involving Hextend in any group of surgical patients and was conducted by a team of physicians led by Kenneth G. Proctor, Ph.D. at the University of Miami Ryder Trauma Center.

1,714 patients were evaluated of which 805 patients received standard of care fluid resuscitation plus up to one liter of Hextend within the first 2 hours of arrival at the trauma center and 909 patients received standard of care fluid resuscitation without Hextend,
While survival was improved in those receiving Hextend, a higher proportion of these patients required ICU admission and transfusions of blood or plasma, consistent with lower mortality and a higher percentage of patients surviving to require subsequent critical care. All results were confirmed using univariate analysis,
Dr. Proctor's team was one of the first to evaluate the potential use of Hextend as a resuscitation fluid in the laboratory.
The U.S. Army has deployed Hextend for initial resuscitation of battlefield casualties because less Hextend is required compared to commonly used saline solution to achieve the same plasma volume expansion effect. This offers a major logistic advantage for a combat medic who has to carry all his supplies in his backpack.

BioTime markets blood plasma volume expanders and related technology for use in surgery, emergency trauma treatment, and other applications. BTIM's lead product, Hextend®, is a blood plasma volume expander manufactured and distributed in the U.S. by Hospira, Inc. and in South Korea by CJ CheilJedang Corp. under exclusive licensing agreements.

 

[BLADEMDA]

Eur J Anaesthesiol. 2008 Dec;25(12):986-94. doi: 10.1017/S026502150800447X. Epub 2008 May 20.
Safety of HES 130/0.4 (Voluven(R)) in patients with preoperative renal dysfunction undergoing abdominal aortic surgery: a prospective, randomized, controlled, parallel-group multicentre trial.
Godet G, Lehot JJ, Janvier G, Steib A, De Castro V, Coriat P.
Source
Université Pierre et Marie Curie, Assistance Publique-Hôpitaux de Paris, Centre Hospitalo-Universitaire Pitié-Salpêtrière, Department of Anesthesiology and Critical Care, Paris, France. [email protected]
Erratum in
Eur J Anaesthesiol. 2008 Dec;25(12):1042.
Abstract
BACKGROUND AND OBJECTIVE:
Patients with impaired renal function are at risk of developing renal dysfunction after abdominal aortic surgery. This study investigated the safety profile of a recent medium-molecular-weight hydroxyethyl starch (HES) preparation with a low molar substitution (HES 130/0.4) in this sensitive patient group.
METHODS:
Sixty-five patients were randomly allocated to receive either 6% hydroxyethyl starch (Voluven); n = 32) or 3% gelatin (Plasmion); n = 33) for perioperative volume substitution. At baseline, renal function was impaired in all study patients as indicated by a measured creatinine clearance < 80 mL min(-1). The main renal safety parameter was the peak increase in serum creatinine up to day 6 after surgery.
RESULTS:
Both treatment groups were compared for non-inferiority (pre-defined non-inferiority range hydroxyethyl starch < gelatin + 17.68 micromol L(-1) or 0.2 mg dL(-1). Other renal safety parameters included minimum postoperative creatinine clearance, incidence of oliguria and adverse events of the renal system. Baseline characteristics, surgical procedures and the mean total infusion volume were comparable. Non-inferiority of hydroxyethyl starch vs. gelatin could be shown by means of the appropriate non-parametric one-sided 95% CI for the difference hydroxyethyl starch-gelatin [-infinity, 11 micromol L(-1)]. Oliguria was encountered in three patients of the hydroxyethyl starch and four of the gelatin treatment group. One patient receiving gelatin required dialysis secondary to surgical complications. Two patients of each treatment group died.
CONCLUSION:
As we found no drug-related adverse effects of hydroxyethyl starch on renal function, we conclude that the choice of the colloid had no impact on renal safety parameters and outcome in patients with decreased renal function undergoing elective abdominal aortic surgery.
Comment in
Kidney damage by hydroxyethyl starch of lower molecular weight and substitution. [Eur J Anaesthesiol. 2009]