Alexandria Journal of Anaesthesia and Intensive Care 44 Autoclaved Gelatin (Haemagel) Versus 6% Hydroxyethyl Starch 200/0.5 (Haes-steril) For Plasma Volume Expansion In Critically-ill Patients Magdy Ali Omera, MD* , Salah A. Ismail, MD* * Assistant Prof. of Anaesthesia, Faculty of Medicine, Suez Canal University. ABSTRACT Synthetic colloids are used to optimize hemodynamics in the critically ill patients and a debate about the most suitable one is still present. The influence of short term infusion of autoclaved gelatin (Haemagel) and 6% hydroxyethyl starch 200/0.5 (Haes-steril) on hemodynamic, respiratory, coagulation, renal and oncotic parameters were examined in a prospective randomized study. Method: Thirty patients suffering from systemic hypoperfusion due to sepsis in ICU of Suez Canal University Hospital were assigned into 2 equal groups. In GEL group: 1000 ml of Haemagel was infused within an hour, while in HES group: 1000 ml of 6% Haes-steril 200/0.5 was given within an hour. The hemodynamic, respiratory, hematological, coagulation, renal and colloidal osmotic pressure parameters were recorded before and after infusion of both colloids. Results: There was a significant similar increase in hemodynamic variables (Mean arterial pressure, central venous pressure, cardiac index, stroke volume index and left ventricular stroke work index) in both groups. Also, a significant improvement in tissue perfusion as judged by decreased arterial lactate was found. There were no significant differences in any of the measured respiratory parameters (respiratory rate, arterial oxygen saturation, arterial blood gases and intrapulmonary shunt) in the studied groups. No significant intergroup difference in any haemodynamic or respiratory variable was demonstrated. A significant expansion in plasma volume as indicated by the significant reduction in haematocrit was detected. There were insignificant changes in coagulation profile (prothrombin time, activated partial thromboplastin time, bleeding time and fibrinogen) in either group except the platelet count which was significantly reduced in both groups without any recorded bleeding complications. Creatinine, blood urea nitrogen, sodium and potassium didn't change and were comparable in the two groups. Colloidal osmotic pressure and urine output increased significantly in either group. Anaphylactic reactions were not observed in any of the patients. However, no significant differences between both groups in haematological, coagulation, renal and oncotic parameters were found. Conclusion: Both autoclaved gelatin (Haemagel) and 6% hydroxyethyl starch 200/0.5 (Haes-steril) are safe and equally effective colloids for plasma volume expansion in critically ill patients without apparent adverse effects on respiration, coagulation and renal functions. INTRODUCTION stabilization. There are several studies In critically-ill patients, acute circula- showing the advantages of colloid solution tory failure is often associated with over crystalloid volume replacement (3,4) intravascular volume depletion which and a debate about the choice of specific contributes to inadequate cardiac output, colloid is still present(5). Although the tissue hypoperfusion, and development of naturally occurring colloidal agent (albumin) multiple organ failure (1). Replacement of is effective for fluid resuscitation, it is also intravascular deficit remains the most very expensive with the potential risk of important therapeutic maneuver in mana- infection(6). Dextran has not been widely gement of those patients to ensure adeq- used because it might result in increased uate cardiac output(2). Whilst crystalloids bleeding, allergic reaction, possible renal are virtually free of major side effects, toxicity and problems with blood cross- they don't necessarily ensure adequate matching(7). volume replenishment or hemodynamic AJAIC-Vol. (8) No. 2 June 2005 Alexandria Journal of Anaesthesia and Intensive Care 45 Hydroxyethyl starch (HES), a synthetic on a clinical ground in the presence of colloid with a high volume expanding sepsis and systemic hypo-perfusion. effect, is produced by hydroxylation of Sepsis was diagnosed, in addition to the starch amylopectin. HES (200/0.5) positive blood culture, by the presence has a molecular weight (200,000 D) of 3 of the following 5 criteria; which allows rapid elimination by kidney tachycardia (HR >100 beat/min), tachy- (8). It also has a low molar substitution pnea (RR >25 breath/min), temperature ratio (0.5) making it more rapidly and (>380C or <360C), leucocytic count completely degraded by circulating (>15,000 or <3,500 /mm3), platelet count amylase with less tissue retention (8). (<150,000 /mm3)(19). Systemic hypo- Since HES has the fewest perfusion was diagnosed by the anaphylactoid reactions among the presence of mean arterial pressure less artificial colloids, it is the most comm.- than 60 mmHg, cardiac index less than only clinically used colloid (9). However, 2.2 L/min/m2 and arterial lactate more large doses of this solution may than 2.0 mmol/L (19). increase bleeding by inducing coagu- Exclusion criteria were patients less lopathy through an effect on factor VIII than 18 years, heart failure, renal activity (8, 10-12). impairment (creatinine > 2 mg/dl and Different colloid solutions containing BUN >100 mg/dl), cerebral hemorrhage, gelatin have been developed. Collagen patients having PT >18 sec, aPTT >45 is degraded via both a thermal effect sec, fibrinogen < 150 mg/dl or Hct <30% producing oxypolygelatin (OPG), and an and allergy to any of the examined enzymatic effect producing either colloids. All patients were assessed by modified fluid gelatin (Gelofusine), or history, full clinical examination, arterial urea cross-linked gelatin (Haemaccel), blood gas analysis, 12 leads ECG and while double degradation and auto- laboratory investigations for the pre- claving producing (Haemagel). Haema- sence of inclusion and exclusion criteria. gel is a balanced salt gelatin-based The included patients were subjected to colloidal solution (100 mL contains 4 g the following: 1] Insertion of arterial line gelatin). It has a higher half-life, no in the dominant radial artery after pseudo agglutination, and no possible modified Allen's testing for sampling of contamination (13). Although researchers arterial blood gas and arterial lactate have studied gelatin for volume (AL) (using ABL 520 Radiometer), replacement, its safety and efficacy colloidal osmotic pressure (using a have not been fully investigated (14-18). Colloid Osmometer (20)). 2] Insertion of So, this study compared autoclaved central venous catheter for measure- gelatin (Haemagel) with 6% hydroxyl- ment of central venous pressure (CVP). ethyl starch 200/0.5 (Haes-steril) in term 3] Insertion of Foley's catheter for of efficacy and safety as a short term measurement of urine output (UOP). 4] volume expander in critically-ill patients. Placing a peripheral venous cannula for laboratory sampling. 5] Connecting the PATIENTS AND METHODS electrodes of thoracic electrical biome- After approval of the local ethics pedence apparatus (TEB), a non-invasive committee and an informed consent haemodynamic monitor (NCCOM-3, Bomed, from each patient or his/her family, thirty Medical manufacturing Ltd., Irvine, CA)(21) critically-ill patients in ICU of Suez Canal for non-invasive measure-ments of cardiac University Hospital suffering from systemic index (CI), stroke volume index (SVI), hypoperfusion due to sepsis were left ventricular stroke work index (LVSWI), enrolled in this study. Inclusion criteria and sys-temic vascular resistance index were patients who required fluid therapy (SVRI). 6] Continuous monitoring of ECG, AJAIC-Vol. (8) No. 2 June 2005 Alexandria Journal of Anaesthesia and Intensive Care 46 heart rate (HR), core temperature physician not involved in the study and (Temp), respiratory rate (RR), arterial who was blind to the grouping. oxygen saturation (SaO2) and non- All results are expressed as means ± invasive mean arterial blood pressure SD. The change in different parameters (MAP) measurement through a continuous compared to the baseline values was display (S/5, Datex Ohmeda, Instru- analyzed using paired t-test. The mentation Corp, Finland). difference between the two groups was Baseline data were recorded before the assessed by one way analysis of variant start of infusion; (ANOVA). A p value <0.05 was A] Patient characteristics: Age, sex, considered statistically significant. weight, height, body surface area (BSA), temperature and clinical diagnosis. RESULTS B] Hemodynamic parameters: HR, Demographic data: MAP, CVP, CI, SVI, LVSWI and SVRI Age, sex, weight, height, BSA, were measured in supine position. temperature and clinical diagnosis were C] Respiratory data: RR, SaO2, arterial comparable in both groups (table 1). blood gases [pH, arterial oxygen tension (PaO2), arterial carbon dioxide tension Hemodynamic parameters: (PaCO2), bicarbonate (HCO3)] and There were no significant differences intrapulmonary shunt [obtained through in baseline hemodynamic values bet- ABL 520 Radiometer]. ween both groups. After infusion, there D] Hematological and coagulation was a significant increase in MAP, CVP, parameters: Haematocrit (Hct), platelet CI, SVI and LVSWI without intergroup count, prothrombin time (PT), activated differences. Significant decreases in partial thromboplastin time (aPTT), SVRI and AL level in addition to an bleeding time (BT) and fibrinogen (22). insignificant change in HR were found in E] Renal function