Hydroxyethyl Starch 130/0.4 and Its Impact on Perioperative Outcome: A Propensity Score Matched Controlled Observation Study

Pagel, Judith-Irina; Rehm, Markus; Kämmerer, T; Hulde, Nikolai; Speck, Eike; Briegel, Josef; Reinholz, Falk; Crispin, Alexander; Hofmann-Kiefer, Klaus

doi:10.1213/ane.0000000000002778

Cited by 19 publications

(6 citation statements)

References 37 publications

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“…As most of the negative effects of HES reported in the RCTs involved patients with sepsis, in 2013 European medicines authorities requested further studies evaluating the safety and efficacy of HES in perioperative non-septic patients (86). Several smaller studies and RCTs in non-septic patients in the perioperative setting found no evidence of a nephrotoxic effect of HES (87,88). Likewise, two recent larger, multicenter trials in 4,545 ("RaFTinG" in 2018) and 775 ("FLASH" in 2020) surgical patients also found no significant difference in mortality between patients who received HES or crystalloids and AKI in one (89), and according to the authors a reduced risk of RRT and AKI in another (90) (Supplementary Table 1).…”

Section: Acute Kidney Injury and Mortalitymentioning

confidence: 99%

Colloids Yes or No? - a “Gretchen Question” Answered

Adamik

Yozova

2021

Front. Vet. Sci.

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Colloid solutions, both natural and synthetic, had been widely accepted as having superior volume expanding effects than crystalloids. Synthetic colloid solutions were previously considered at least as effective as natural colloids, as well as being cheaper and easily available. As a result, synthetic colloids (and HES in particular) were the preferred resuscitation fluid in many countries. In the past decade, several cascading events have called into question their efficacy and revealed their harmful effects. In 2013, the medicines authorities placed substantial restrictions on HES administration in people which has resulted in an overall decrease in their use. Whether natural colloids (such as albumin-containing solutions) should replace synthetic colloids remains inconclusive based on the current evidence. Albumin seems to be safer than synthetic colloids in people, but clear evidence of a positive effect on survival is still lacking. Furthermore, species-specific albumin is not widely available, while xenotransfusions with human serum albumin have known side effects. Veterinary data on the safety and efficacy of synthetic and natural colloids is limited to mostly retrospective evaluations or experimental studies with small numbers of patients (mainly dogs). Large, prospective, randomized, long-term outcome-oriented studies are lacking. This review focuses on advantages and disadvantages of synthetic and natural colloids in veterinary medicine. Adopting human guidelines is weighed against the particularities of our specific patient populations, including the risk–benefit ratio and lack of alternatives available in human medicine.

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Section: Acute Kidney Injury and Mortalitymentioning

confidence: 99%

Colloids Yes or No? - a “Gretchen Question” Answered

Adamik

Yozova

2021

Front. Vet. Sci.

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“…In critically ill humans, HES exposure has been linked to an increased incidence of AKI and the need for renal replacement therapy, particularly in patients affected by sepsis or burns, whereas studies conducted in patients undergoing surgery have reported contrasting results [ 7 , 21 , 22 , 23 , 24 , 25 , 26 ]. Datzmann et al assessed some functional renal parameters and structural biomarkers (including NGAL) in people undergoing coronary bypass grafting without showing differences in mortality, acute kidney injury, the need for renal replacement therapy, or evidence of a mechanism for tubular injury [ 25 ].…”

Section: Discussionmentioning

confidence: 99%

Stage 1-Biomarkers of Kidney Injury in Dogs Undergoing Constant Rate Infusion of Hydroxyethyl Starch 130/0.4

Bruno

Troìa

Dondi

et al. 2021

Animals

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In veterinary medicine, investigations relating the effects of hydroxyethyl starch (HES) on renal function report contrasting results. This study aimed to assess the changes in the selected biomarkers of kidney injury in dogs after the administration of HES 130/0.4 as a constant rate infusion (CRI) for 24 h. Ten adult client-owned dogs with hypoalbuminemia (albumin < 2 g/dL) and ongoing fluid losses were included. Enrolled dogs received intravenous fluid therapy with crystalloids and a CRI of HES 130/0.4 at a dose of 2 mL/kg/h for 24 h. Serum creatinine (sCr), fractional excretion (FE) of electrolytes, urinary protein to creatinine ratio (UPC), urinary albumin to creatinine ratio (UAC), SDS-page, and urinary neutrophil gelatinase-associated lipocalin (uNGAL) were measured at the baseline before HES infusion, and after 24 h (T24) and 48 h (T48) from the baseline. No statistically significant difference was found between the baseline value vs. T24 and the baseline vs. T48 for sCr, UAC, UPC, FE of sodium, chloride and calcium, and uNGAL. A significant increase in FEK (p = 0.04) was noticed between the baseline and T48. In this study sample of hypoalbuminemic dogs, HES 130/0.4 at the dose and rate of infusion applied did not cause any significant changes in the investigated biomarkers of kidney injury.

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“…Among many studies reporting no negative safety profile of HES 130/0.4 in each unique type of surgery [12,14,16,[19][20][21]33], our study covering the entire types of surgery would have a greater generalizability. The manufacturer and distributor of HES 130/0.4 in Japan funded this study.…”

Section: Strengths and Limitations Of The Studymentioning

confidence: 99%

“…Studies of critically ill nonsurgical patients showed that colloids, including albumin and hydroxyethyl starch (HES), were no better and sometimes less effective than crystalloids in reducing renal morbidity [6][7][8][9][10]. However, in studies of surgical patients, the newest preparation of 6% HES 130/0.4 (Voluven ® ; Fresenius Kabi GmbH, Germany) was not associated with renal damage [11][12][13][14][15][16]. A recent multicenter randomized trial for high-risk abdominal surgery compared HES 130/0.4 with crystalloid using Doppler-guided GDFT and showed no evidence of renal toxicity in patients receiving HES 130/0.4 [11].…”

Section: Introductionmentioning

confidence: 99%

Postoperative renal morbidity and mortality after volume replacement with hydroxyethyl starch 130/0.4 or albumin during surgery: a propensity score-matched study

Miyao

Kotake

2020

J Anesth

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Purpose We aimed to compare retrospectively the rates of renal morbidity and mortality in surgical patients receiving 6% HES 130/0.4 to those receiving albumin. Methods From a Japanese nationwide medical database between 2014 and 2016, we identified adults who received HES 130/0.4 (HES group) or albumin (albumin group) as a single colloid solution on the day of surgery. After propensity score matching, the two groups were analyzed with χ 2 or Mann Whitney U test. The primary outcome was the incidence of acute kidney injury (AKI). Secondary outcomes included the incidence of renal-replacement therapy, hospital length of stay, inhospital 30-day mortality, the use of vasoactive agents, and the fluid requirement on the day of surgery. Results Of 76,048 patients in the database, propensity score matching identified 289 matched pairs. There was no statistically significant difference in the incidence of AKI between the HES and the albumin group (15.2% vs. 20.8%, respectively: P = 0.08). The secondary outcomes did not differ between groups except the following. Median hospital stay was 5 days shorter in the HES group (18 vs. 23 days; P < 0.001), and the median net fluid requirement on the day of surgery was 15 mL/ kg lower in the HES group (140 vs. 155 mL/kg, respectively; P = 0.01). Conclusions Postoperative renal morbidity and mortality did not differ between patients receiving HES 130/0.4 and those receiving albumin. HES 130/0.4 was associated with shorter hospital stay and less fluid requirement compared to albumin. These findings support the use of 6% HES 130/0.4 for perioperative volume replacement as an alternative to albumin. Trial registration UMIN000027896 and the date of registration was June 30, 2017 at https ://www.umin.ac.jp/ctr/index-j.html.

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Hydroxyethyl Starch 130/0.4 and Its Impact on Perioperative Outcome: A Propensity Score Matched Controlled Observation Study

Abstract: An association between intraoperative HES therapy and postoperative kidney failure was not observed in a mixed cohort of elective surgical patients. In addition, HES 130/0.4 was not associated with an increased morbidity or the need for ICU therapy in this propensity score matched study.

Cited by 19 publications

References 37 publications

Colloids Yes or No? - a “Gretchen Question” Answered

Colloids Yes or No? - a “Gretchen Question” Answered

Stage 1-Biomarkers of Kidney Injury in Dogs Undergoing Constant Rate Infusion of Hydroxyethyl Starch 130/0.4

Postoperative renal morbidity and mortality after volume replacement with hydroxyethyl starch 130/0.4 or albumin during surgery: a propensity score-matched study

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