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netherlands journal of critical care Table 3: Fluids in sepsis Author/Trial name Number of patients Design Kind of fluid used renal outcome Evidence Schortgen F. et al. 129 RCT 6% HES vs. 3% gelatine gelatine better level I SAFE Study 6997 RCT albumin vs. saline no difference level I Stockwell MA et al. 475 RCT albumin vs. polygeline no difference level I Table 4: Fluids in relative hypovolemia Author/Trial name Number of patients Design Kind of fluid used renal outcome Evidence Sort P et al. 126 RCT albumin or no fluid better with albumin level I Gines P et al. 105 RCT albumin or no albumin better with albumin level I Gines A et al. 289 RCT albumin vs. dextran vs. polygeline no difference level I Table 5: Fluids for prevention of contrast nephropathy Author Number of patients Design Kind of fluid used renal outcome Evidence Merten GJ et al. 119 RCT bicarbonate-containing 5% glucose (1) vs. saline (2) 1 better than 2 level II Mueller C et al. 1620 RCT isotonic vs. half-isotonic isotonic hydration better level I Solomon R et al. 78 RCT 0,45 % saline (1) alone vs. 1+ mannitol vs. 1 + furosemide 0,45% saline best level I Trivedi HS et al. 53 RCT normal saline I.V. vs. deliberate oral fluid intake I.V. saline better level II • The following endpoints were extracted: Physiological endpoints: - Creatinine clearance (CrCl), glomerular filtration rate (GFR), increase in serum creatinine (∆SCr) Clinical endpoints: - Need for renal replacement therapy (RRT) - Mortality Studies were graded using the five level system described by Dellinger and co-workers [32]. In this study, the cut-off for a large and a small randomised controlled trial was arbitrarily set at 50 patients per group and a meta-analysis was graded as Level I. True hypovolaemia (surgery, trauma) Several studies have investigated the effects of volume expansion in hypovolaemia or expected hypovolaemia during various kinds of surgery (Table 2). A small RCT compared lactated Ringers´ solution to three different forms of HES in patients with normal renal function undergoing middle ear surgery. Neither fluid was found to have any effect on renal function [33]. The same lack of effect on renal function was found in a large RCT comparing saline to 4% albumin [17]. Most studies compared different colloids (i.e. mainly HES vs gelatin, albumin or dextrans)[18;34-39] without showing any particular benefit on renal function from any of the solutions. However, a retrospective study, reported reduced mortality in patients undergoing coronary artery bypass surgery and receiving albumin in comparison to synthetic colloids (level III) [40].On the other hand, in a recent large retrospective study on 238 cardiac surgery patients, perioperative administration of HES (670/0.75) was associated with significant decrease of glomerular filtration rate (GFR) of an estimated magnitude of 14 ml/min/1.73m 2 per every 2 HES units given (level III) [30]. The degree of renal impairment associated with different forms of HES seems to be related to their molecular weight as well as to the degree of molar substitution, although adverse renal effects have been reported with all commercially available HES forms. Only one study compared volume replacement versus no volume replacement- that of Bickel and co-authors (level III) [41]. In this RCT studying hypotensive patients with penetrating torso injuries, delay of aggressive fluid resuscitation until operative intervention significantly reduced mortality when compared to early volume resuscitation. Additionally a trend towards a lower incidence of renal failure was found in the delayed group. Taking the existing evidence, normal saline, although it has less effect on volume, clearly cannot be classified as inferior to colloids. Among the colloids, it seems prudent to avoid HES, especially large molecular weight containing HES, in patients with pre-existing renal impairment. Sepsis Beneficial effects of volume replacement in sepsis have been investigated in several trials (Table 3). In a rat model of sepsis [42] fluid resuscitation was successful in restoring the glomerular filtration rate if it was initiated at the moment that the bacterial inoculum was present, but not if it was started at the moment endotoxaemia was induced. Similar findings in humans were obtained by a prospective study (level III)[43] which showed that in deteriorating renal function, further fluid loading is not likely to reverse ARF in patients in whom the septic cascade has already started. Early volume resuscitation, however, along with other measures applied in sepsis to reach certain targets of oxygen delivery, results in less organ failure and reduced mortality (level I)[44]. In this study both colloids and crystalloids were given depending on physician’s preference. Schortgen and co-workers compared 6% HES 130/0.62 (n=65) to gelatin (n=64) and showed lower serum creatinine levels in the group receiving gelatin with no effect on RRT or outcome (level I)[19]. In a recent multicentre RCT, albumin was compared to isotonic sodium chloride in various situations including sepsis and without finding any difference in impact on renal function (level I)[17]. A single centre RCT of ICU patients comparing volume substitution with 5% HA or gelatin could not find any difference in renal function despite significant differences in serum albumin (level I) [35] . Finally, a comparison of several forms of HES in ICU patients did not demonstrate differences in renal function (level II) [45]. Relative or unrecognized hypovolaemia Relative or unrecognised hypovolaemia (with respect to effective circulating volume) are clinical situations which are often missed and occur for example in diuretic therapy in the elderly, liver cirrhosis, heart failure and positive pressure mechanical ventilation. In an earlier study on the effect of diuretics on ICU patients with renal failure, renal function recovered in about 25% of patients after simple fluid replacement, indicating the presence of unrecognised pre-renal failure (level III) [46]. Therefore, many authors recom- 550 neth j crit care • volume 10 • no 5 • october 2006
netherlands journal of critical care mend a fluid challenge in ICU patients with deteriorating renal function [47]. Unfortunately, no randomised trial has ever evaluated the impact of fluid loading as a single intervention in this patient group. Mechanical ventilation per se is known to be a risk factor for ARF and application of positive end-expiratory pressure (PEEP) in mechanically ventilated patients induces a decrease in glomerular filtration rate, renal blood flow and free water clearance, and the effect may be worsened by concurrent volume depletion [51]. The effect of volume substitution in this setting however has not been investigated in a controlled trial. An earlier RCT in patients with liver cirrhosis undergoing paracentesis, found a highly significant reduction of the incidence of renal failure after albumin substitution (level I, Table 4) [48]. If either 20% HA, dextrans or gelatin were substituted as volume replacement (level I) [49], no difference in either creatinine clearance, the incidence of ARF or outcome was observed in any of these three substitution groups. Furthermore, a trial in patients with liver cirrhosis and spontaneous bacterial peritonitis (SBP) showed improved outcome with intravenous HA (level I) [50]. Prevention of nephrotoxic renal injury Hypovolaemia is a major risk factor for most forms of drug-induced renal failure [52]. On the other hand, it has been shown to be preventable in some instances by adequate hydration. No trials exist that systematically investigate the ideal solution and the amount to be administered. However, clinical reports /studies mainly document the use of normal saline. Prophylaxis by volume expansion has been demonstrated for amphotericin B [53], antiviral drugs like foscarnet [54], cidofovir and adefovir [55] as well as drugs inducing crystal nephropathy, i.e. indinavir, acyclovir, and sulfadiazine [56]. Furthermore this effect has been shown for cisplatin [57] and for tumour lysis syndrome [58]. At best available studies only reach level IV and only one study can be classified as level II [54]. Contrast nephropathy Hydration appears to be the most effective preventive measure for contrast nephropathy (Table 5). Initial studies investigating the protective role of hydration in contrast nephropathy used historical controls [59]. Nearly all studies investigating potentially protective drugs like N-acetyl-cysteine or theophylline in this setting use hydration with normal saline in their control groups. Intravenous 0.45% saline was shown to be superior to both mannitol and furosemide in a larger RCT [60]. Another RCT (n= 1383) patients showed that normal saline is superior to half normal saline in reducing the incidence of contrast nephropathy in patients undergoing coronary angiography (0.7% vs. 2%) (level I) [61]. Additionally, intravenous normal saline (1 ml/kg/h) was found to be superior to oral fluid administration in a small trial (n=53) (level II) [62]. In a recent prospective observational study the incidence of contrast nephropathy was kept very low (1.4%) simply by keeping patients well hydrated, both intravenously and orally [63]. A recent trial suggests it is beneficial to use isotonic sodium-bicarbonate instead of normal saline (level I) [64]. Colloids were not investigated. Myoglobinuria - Crush injury Renal failure due to crush injury is a consequence of both hypovolaemia due to volume loss into the third space (e.g. injured limb) and toxic injury due to myoglobinuria/haemoglobinuria. Reports from larger case series show significantly improved outcome and reduced rate of ARF in patients with crush injury who were hydrated with normal saline (level III) [65] [66;67]. Sodium bicarbonate in combination with mannitol did not significantly contribute to improved outcome (level III) [68]. Potential problems of volume expansion As already noted, there may be situations where further fluid loading may even cause outcomes to deteriorate. Clearly fluid loading is contraindicated in patients with severe heart failure and lung oedema. Furthermore in a prospective observational trial of 2 442 patients admitted to the ICU, it was shown that in deteriorating renal function further fluid loading is not likely to reverse ARF if the septic cascade has already started [43] (level III). Furthermore, they found no evidence that hypovolaemia was a cause of ARF in patients with normal renal function who developed sepsis. Aggressive fluid loading does not seem to prevent further evolution to ARF, and may potentially induce tissue oedema, particularly in the lung and gut mucosa [69]. Thus, fluid loading must be initiated to achieve well-defined endpoints such as central venous pressure (8-12 mmHg) and SvO2 (>70%) in septic shock or hypovolaemia [70]. A minimal urinary output (e.g. 100-150 ml/h) is often recommended to avoid potential nephrotoxic renal injury. Final recommendations • Volume expansion by fluids is generally recommended as the primary and most effective measure for prevention of acute renal failure in states of true or suspected hypovolaemia and sepsis (Grade A). • Volume expansion using isotonic saline is recommended for protection in certain instances of drug induced nephrotoxicity (amphotericin B, foscarnet, cidofovir, adefovir, indinavir, acyclovir, sulfadiazine (Grade D, E), and cisplatin (Grade B). • Intravenous normal saline is recommended for prevention of contrast nephropathy (Grade A). Bicarbonate containing solutions may be a better option. (Grade B) • Given the still unresolved debate regarding the influence of HES on renal function, HES can not be recommended as a first-line option for volume resuscitation in a broad range of patients (Grade B). • If HES is given, it is recommended that low-molecular HES preparations be used. (Grade C). • If HES is given, sufficient quantity of free water must be co-administered to minimize the risk of renal dysfunction (Grade E). • In large volume paracentesis in patients with liver cirrhosis, application of colloids and in particular albumin, is more effective in preserving renal function than crystalloids (Grade A). • Uncontrolled volume substitution may result in oedema as well as abdominal compartment syndrome and should be avoided (Grade C). • In hypotensive patients with penetrating torso injuries, aggressive fluid resuscitation may be delayed until operative intervention (Grade B) • Fluid loading should be performed to achieve well-defined end points of resuscitation such as SvO 2 , CVP, cardiac output and urinary output. neth j crit care • volume 10 • no 5 • october 2006 551
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