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Diagnostic value of plasma NGAL and intraoperative diuresis for AKI after major gynecological surgery in patients treated within an intraoperative goal-directed hemodynamic algorithm: A substudy of a randomized controlled trial.

ABSTRACT: Data on early markers for acute kidney injury (AKI) after noncardiovascular surgery are still limited. This study aimed to determine the diagnostic value of plasma neutrophil-gelatinase-associated lipocalin (pNGAL) and intraoperative diuresis for AKI in patients undergoing major abdominal surgery treated within a goal-directed hemodynamic algorithm.This study is a post-hoc analysis of a randomized controlled pilot trial comparing intravenous solutions within a hemodynamic goal-directed algorithm based on the esophageal Doppler in patients undergoing epithelial ovarian cancer surgery. The diagnostic value of plasma NGAL obtained at ICU admission and intraoperative diuresis was determined with respect to patients already meeting AKI criteria 6?hours after surgery (AKI6h) and to all patients meeting AKI criteria at least once during the postoperative course (AKItotal). AKI was diagnosed by the definition of the Kidney Disease Improving Global Outcome (KDIGO) group creatinine criteria and was screened up to postoperative day 3. Receiver operating characteristic curves including a gray zone approach were performed.A total of 48 patients were analyzed. None of the patients had increased creatinine levels before surgery and 14 patients (29.2%) developed AKI after surgery. Plasma NGAL was predictive for AKI6h (AUCAKI6h 0.832 (95% confidence interval [CI], 0.629-0.976), P?=?.001) and AKItotal (AUCAKItotal 0.710 (CI 0.511-0.878), P?=?.023). The gray zones of pNGAL calculated for AKI6h and AKItotal were 210 to 245 and 207 to 274 ng mL, respectively. The lower cutoffs of the gray zone at 207 and 210 ng mL had a negative predictive value (NPV) (i.e., no AKI during the postoperative course) of 96.8% (CI 90-100) and 87.1% (CI 78-97), respectively. Intraoperative diuresis was also predictive for AKI6h (AUCAKI6h 0.742 (CI 0.581-0.871), P?=?.019) with a gray zone of 0.5 to 2.0 mL kg h. At the lower cutoff of the gray zone at 0.5 mL kg h, corresponding to the oliguric threshold, the NPV was 84.2% (78-92).This study indicates that pNGAL can be used as an early marker to rule out AKI occurring within 3 days after major abdominal surgery. Intraoperative diuresis can be used to rule out AKI occurring up to 6?hours after surgery.ISRCTN 53154834.

SUBMITTER: Hunsicker O

PROVIDER: S-EPMC5515745 | biostudies-literature | 2017 Jul

REPOSITORIES: biostudies-literature

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Diagnostic value of plasma NGAL and intraoperative diuresis for AKI after major gynecological surgery in patients treated within an intraoperative goal-directed hemodynamic algorithm: A substudy of a randomized controlled trial.

Hunsicker Oliver O Feldheiser Aarne A Weimann Andreas A Liehre David D Sehouli Jalid J Wernecke Klaus-Dieter KD Spies Claudia C

Medicine 20170701 28

Data on early markers for acute kidney injury (AKI) after noncardiovascular surgery are still limited. This study aimed to determine the diagnostic value of plasma neutrophil-gelatinase-associated lipocalin (pNGAL) and intraoperative diuresis for AKI in patients undergoing major abdominal surgery treated within a goal-directed hemodynamic algorithm.This study is a post-hoc analysis of a randomized controlled pilot trial comparing intravenous solutions within a hemodynamic goal-directed algorithm ...[more]

PMID: 28700473

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Project description:(1) Background: The Hypotension Prediction Index (HPI) is an algorithm that predicts hypotension, defined as mean arterial pressure (MAP) less than 65 mmHg for at least 1 min, based on arterial waveform features. We tested the hypothesis that the use of this index reduces the duration and severity of hypotension during noncardiac surgery. (2) Methods: We enrolled adults having moderate- or high-risk noncardiac surgery with invasive arterial pressure monitoring. Participating patients were randomized 1:1 to standard of care or hemodynamic management with HPI guidance with a goal directed hemodynamic treatment protocol. The trigger to initiate treatment (with fluids, vasopressors, or inotropes) was a value of HPI of 85 (range, 0-100) or higher in the intervention group. Primary outcome was the amount of hypotension, defined as time-weighted average (TWA) MAP less than 65 mmHg. Secondary outcomes were time spent in hypertension defined as MAP more than 100 mmHg for at least 1 min; medication and fluids administered and postoperative complications. (3) Results: We obtained data from 99 patients. The median (IQR) TWA of hypotension was 0.16 mmHg (IQR, 0.01-0.32 mmHg) in the intervention group versus 0.50 mmHg (IQR, 0.11-0.97 mmHg) in the control group, for a median difference of -0.28 (95% CI, -0.48 to -0.09 mmHg; p = 0.0003). We also observed an increase in hypertension in the intervention group as well as a higher weight-adjusted administration of phenylephrine in the intervention group. (4) Conclusions: In this single-center prospective study of patients undergoing elective noncardiac surgery, the use of this prediction model resulted in less intraoperative hypotension compared with standard care. An increase in the time spent in hypertension in the treatment group was also observed, probably as a result of overtreatment. This should provide an insight for refining the use of this prediction index in future studies to avoid excessive correction of blood pressure.

Project description:While hydroxyethyl starch (HES) solutions are not recommended any longer in critically ill patients, data on efficacy and safety during surgery are still limited.In a randomized controlled trial 63 patients were assigned to receive 10% HES (130/0.42), 6% HES (130/0.42), or crystalloid within a goal-directed hemodynamic algorithm during pancreatic surgery. The primary endpoints were intraoperative volume of HES and time until fully on oral diet.The trial was terminated early upon recommendation of an independent data monitoring committee due to futility for efficacy at a planned interim analysis. The intraoperative volume of HES was not different between 10% and 6% HES group (2000 [1500; 2250] vs 2250 [1750; 3000] mL, P=.059). However, considering an inhomogeneity of patient's body weight between HES groups, there was a significant difference in intraoperative volume of HES between 10% and 6% group after adjusting for patient's body weight (24.0 [21.6; 28.3] vs 33.3 [28.2; 46.2] mL kg BW, P?=?.002). Patients in the HES groups required less additional fluid after dose limit than those in the crystalloid group, resulting in lower intraoperative net balances. The time until fully on oral diet was not different between all study groups. Applying KDIGO oliguria criterion, patients receiving 10% HES had more AKI compared to patients receiving crystalloids (86.7 vs 45.0%, P?=?.010), whereas those receiving 6% HES and crystalloids did not differ (58.8 vs 45.0%, P?=?.253). Further explorative analyses using a gray-zone approach indicated that patients receiving 6% HES below 18.8 mL kg will not experience AKI with near certainty.After adjusting for patient's body weight, patients receiving 6% HES required more volume of HES than patients receiving 10% HES. The relation of 140% represents very well the volume effect of a hyperoncotic 10% HES solution. Nonetheless, both HES solutions were similarly effective in reducing intraoperative fluid administration compared with crystalloid, but this did not result into differences in gastrointestinal outcomes. Patients receiving 10% HES showed an increased rate of AKI, whereas those receiving 6% HES and crystalloid did not differ. However, 6% HES should not be applied beyond 18 mL kg during surgery.

Project description:BackgroundPerioperative goal-directed therapy (GDT) reduces the risk of renal injury. However, several questions remain unanswered, such as target, kind of patients and surgery, and role of fluids and inotropes. We therefore update a previous analysis, including all studies published in the meanwhile, to clarify the clinical impact of this strategy on acute kidney injury.Main bodyRandomized controlled trials enrolling adult patients undergoing major surgery were considered. GDT was defined as perioperative monitoring and manipulation of hemodynamic parameters to reach normal or supranormal values by fluids alone or with inotropes. Trials comparing the effects of GDT and standard hemodynamic therapy were considered. Primary outcome was acute kidney injury, whichever definition was used. Meta-analytic techniques (analysis software RevMan, version 5.3) were used to combine studies, using random-effect odds ratios (OR) and 95% confidence intervals (CI). Trial sequential analyses were performed including all trials and considering only low risk of bias trials. Sixty-five trials with an overall sample of 9308 patients were included. OR for the development of renal injury was 0.64 (95% CI, 0.62-0.87; p = 0.0003), with no statistical heterogeneity. Trial sequential analyses and sensitivity analysis including studies with low risk of bias confirmed the main results. A significant decrease in renal injury rate was observed in studies that adopted cardiac output and oxygen delivery as hemodynamic target and that used both fluids and inotropes. The postoperative kidney injury rate was significantly lower in trials enrolling "high-risk" patients and major abdominal and orthopedic surgery.Short conclusionThe present meta-analysis suggests that targeting GDT to perioperative systemic oxygen delivery, by means of fluids and inotropes, can be the best way to improve renal perfusion and oxygenation in high-risk patients undergoing major abdominal and orthopedic surgery.

Project description:A randomized, controlled trial, intended to include 460 patients, is currently studying peroperative goal-directed hemodynamic treatment (GDHT) of aged hip-fracture patients. Interim efficacy analysis performed on the first 100 patients was statistically uncertain; thus, the trial is continuing in accordance with the trial protocol. This raised the present investigation's main question: Is it reasonable to continue to fund the trial to decrease uncertainty? To answer this question, a previously developed probabilistic cost-effectiveness model was used. That model depicts (1) a choice between routine fluid treatment and GDHT, given uncertainty of current evidence and (2) the monetary value of further data collection to decrease uncertainty. This monetary value, that is, the expected value of perfect information (EVPI), could be used to compare future research costs. Thus, the primary aim of the present investigation was to analyze EVPI of an ongoing trial with interim efficacy observed.A previously developed probabilistic decision analytic cost-effectiveness model was employed to compare the routine fluid treatment to GDHT. Results from the interim analysis, published trials, the meta-analysis, and the registry data were used as model inputs. EVPI was predicted using (1) combined uncertainty of model inputs; (2) threshold value of society's willingness to pay for one, quality-adjusted life-year; and (3) estimated number of future patients exposed to choice between GDHT and routine fluid treatment during the expected lifetime of GDHT.If a decision to use GDHT were based on cost-effectiveness, then the decision would have a substantial degree of uncertainty. Assuming a 5-year lifetime of GDHT in clinical practice, the number of patients who would be subject to future decisions was 30,400. EVPI per patient would be €204 at a €20,000 threshold value of society's willingness to pay for one quality-adjusted life-year. Given a future population of 30,400 individuals, total EVPI would be €6.19 million.If future trial costs are below EVPI, further data collection is potentially cost-effective. When applying a cost-effectiveness model, statements such as 'further research is needed' are replaced with 'further research is cost-effective and 'further funding of a trial is justified'.ClinicalTrials.gov NCT01141894.

Dataset Information

Diagnostic value of plasma NGAL and intraoperative diuresis for AKI after major gynecological surgery in patients treated within an intraoperative goal-directed hemodynamic algorithm: A substudy of a randomized controlled trial.

Publications

Diagnostic value of plasma NGAL and intraoperative diuresis for AKI after major gynecological surgery in patients treated within an intraoperative goal-directed hemodynamic algorithm: A substudy of a randomized controlled trial.

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