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The primary treatment and management of patients diagnosed with sepsis is the resuscitation of fluids. The ideal volume and composition of the resuscitation fluids are currently unknown ( Carlsen & Perner, 2011). The estimated number of patients per year diagnosed with severe sepsis tops 750,000 in the United States and reaches up to 19 million worldwide. Sepsis presents with a short -term mortality rate of 20% -30% and exceeds up to 50% when shock is present in the body. Sepsis death rates continue to rise in the United States and is the leading cause of death among hospitalized patients in non- coronary intensive care units (Jiang, et al., 2014). However, e arly administration of fluid resuscitation interventions is key in the management of sepsis.

Nevertheless , the appropriate use of fluid therapy remains controversial. Therefore, the question arises, in critical care patients, how does albumin resuscitation compared to saline resuscitation affect sepsis? The independent variable (IV) in the study is th e use of albumin- containing fluids and the dependent variable (DV) would be how this affects patients diagnosed with sepsis. The aim of this integrative review is to conduct a review of the literature using a systematic approach for current research and sy nthesize these research studies of albumin resuscitation compared to saline resuscitation in critical care patients with sepsis to validate a Critical Care Center for Patient Innovation program at Tennessee Memorial Hospital. Running head: FLUID RESUSCITATION 4 Literature Review Design and Data Sources. Systemic literature searches were performed from CINAHL, MEDLINE, and Cochrane Database of Systemic Review databases from 2011 to 2019 for previously published peer -reviewed studies . These databases were chosen for the searching of evidence -based scholarly -reviewed articles to validate credible and reliable studies. CINAHL database provides t he top nursing and allied health literature available including nursing journals and publications from the National League for Nursing and the American Nurses Association.

Literature covers a wide variety of topics from biomedicine to allied health disciplines.

MEDLINE is a bibliographic database of life sciences and biomedical information. It includes academic journals covering medicine, nursing , pharmacy, dentistry, veterinary medicine, and healthcare. Cochrane Database of Systemic Review is a library consisting of collections of databases in medicine and other healthcare specialties. Initial key word searches included fluid resuscitation, sepsi s, saline, albumin-containing solutions, and crystalloids . Further restriction of key words and MeSH terms included meta -analysis, systematic- review, sepsis, albumin, and resuscitation yielded considerable results with reliable and expedient information. U tilizing MeSH terms such as albumin and resuscitation and sepsis produced relevant research articles to include those specific key words in correlation with the PICO being addressed. Inclusion criteria for this integrated review were journals and articles that were peer reviewed with information on fluid resuscitation for sepsis patients and published between 2011 and 2019. Exclusions consisted of any articles beyond the year 2011 in order to narrow the search. Journal and articles that did not contain information on sepsis patients or did not have supportive data were also excluded. All articles were evaluated for high est level of evidence (LOE). Running head: FLUID RESUSCITATION 5 Methodology Analysis Review method. A five -stage integrative review method was used. This method consisted of (a) problem formulation was developed using a PICO format, in critical care patients, how does albumin resuscitation compared to saline resuscitation affect sepsis, (b) searches of these evidence -based databases, CINAHL, MEDLINE, and Cochrane Library by us ing the key words fluid resuscitation, sepsis, saline, albumin- containing solutions, and crystalloids and MeSH terms included meta -analysis, systematic -review, sepsis, albumin, and resuscitation (c) evaluation of data, (d) data analysis and interpretation, and (e) presentation of results in an evidence table by the identification and evaluation of what was used to review and synthesize current knowledge. Focus of this review on fluid resuscitation in sepsis was narrowed towards articles less than eight years old with a focus on systematic reviews and meta -analysis for high est level of evidence (LOE). Any and all articles from blogs, books, and Google or Google Scholar were excluded due to lack of credibility and reliability. The dependent and independent variable search terms lead to the majority of articles and journals chosen being systematic reviews and meta- analysis. These findings indicate that the articles contain high level of evidence (LOE) and reliability. Synthesis and Interpretation Results. Using standard process for conducting an integrative review, six peer -reviewed research studies published in refereed journals were analyzed and synthesized. According to the synthesis of these studies, the use of albumin- containing products versus normal saline resuscitation therapy demonstrated no significant advantage in patients with any severity of sepsis. The research strategies used to gather information consisted of predominantly randomized controlled trials (RCTs) with secondary data such as systematic reviews and meta- analysis in Running head: FLUID RESUSCITATION 6 quantitative research methods . These studies followed a logical manner with a clear and evident link beginning with the purpose of the study following through. These sources were objective with no bias noted in the resear ch studies reviewed, with the exception of Annals of Internal Medicine and The American Journal of Emergency Medicine . The risk of bias for individual studies and quality of evidence were assessed and was found within the limitations. These trials were het erogenous in case mix, fluids evaluated, and duration of fluid exposure. Imprecise estimates for several comparisons in this network meta -analysis contribute to low confidence in most estimates of effect (Rochwerg, et al., 2014). Data was collected in numerous ways however randomized trials was leading . Carlsen & Perner (2011) consisted of a prospective cohort study of all patients with sepsis or septic shock admitted in six intensive care units during a three -month period. Patients were divided into tw o groups according to the overall median volume of resuscitation fluid administered during the first twenty -four hours after the diagnosis. Jiang, et al., (2014) consisted of fifteen eligible randomized controlled trials for analysis. Several predefined su bgroup analyses were performed according to patient age (adult or pediatric), type of resuscitation fluid (crystalloids or gelofusine or starch), concentration of albumin (4% to 5% solution or 20% to 25% solution), follow -up interval (intensive care unit mortality, hospital mortality, 28/30 day mortality and ninety day mortality), disease severity (sepsis, sever sepsis, septic shock), and definition of sepsis. Despite the subgrouping of this particular study, there was no significant effect of albumin- containing fluids on mortality in patients with sepsis of any severity. While the difference in mortality between groups did not reach statistical significance, these findings indicate that 4% to 5% albumin may be safer than 20% to 25% albumin for fluid resusci tation in patients diagnosed with Running head: FLUID RESUSCITATION 7 sepsis of any severity. Conclusive to this, further studies are implausible to change the existing conclusion. Despite best efforts of research and data collection methods, gaps and inconsistences were present throughout this review process with indications of observable limitations. Rochwerg, et al., (2014) trials consisted of heterogenous trials, fluids assessed, extent of exposure, and risk of bias. These factors have the potential to alter conclusions. Liu, et al., (2019) meta -analysis comprised of potential limitations. Subgroup and sensitivity analyses were of difficulty to perform due to lack of data. Patients that were included in this meta -analysis presented with varying levels of secondary trauma such as acute pan creatitis which resulted in heterogeneity.

There was potential for partial recovery of identified research studies, introducing bias. Carlsen & Perner (2011) impedes strong conclusions regarding the effects of fluid resuscitation for septic patients. Gaps for this study includes the lack of timing and rate of fluid infusion assessment by clinicians. The majority of patients in this research method were given broad- spectrum antibiotics before the absolute diagnosis, but those who had not received them did not present with an inferior outcome. Despite the limitations and gaps present, this study was solely observational in design. Delaney, et al., (2011) consisted of a meta -analysis that presented with non- optimal methodological quality. The results of this an alysis differ from those of previous meta -analyses of albumin in patients with sepsis or severe sepsis. This method focused on a specific population rather than heterogenous populations such as others. Jiang, et al., (2014) meta -analysis presented with het erogeneity between different studies and the methodological quality of all studies included in this research was adaptable. Running head: FLUID RESUSCITATION 8 Ethical Concerns Ethical concerns. There were no present concerns of ethics in the creation and implementation in any of these reviewed studies. The ethics committee of Copenhagen and the Danish Data Protection Agency approved the study of Carlsen & Perner, (2011). All other studies were deemed ethical and declared no conflict of interest . Conclusion Strengths. The strength of t hese reviews is included in a precise clinical question that is limited to patients with sepsis rather than critically ill patients as a whole. The strength lies in the focus of resuscitation rather than the maintenance of fluid therapy. Studies consisted of inclusions of patients in intensive care units and comprised of follow -up with the National Patient Registry using national patient identification numbers.

Limitations. The patterns of limitations varied between studies reviewed based on population, stu dy size, demographics and control or subgroups being most prevalent. Despite the present gaps and inconsistencies in each study, they were efficient in concluding the result of albumin- containing products versus saline in fluid resuscitation not demonstrat ing an increase in mortality rates in patients with sepsis. Validity and Reliability. The results of all studies reviewed deemed reliable and valid as indication of highest level of evidence (LOE). All studies presented with strong level I of evidence excluding Carlsen & Perner, (2011), which consists of LOE II. Studies revealed reliable as confirmation of strong sources, authors, and year published. Studies supported each other with aligning evidence and outcomes in relation to albumin versus saline resus citation in patients with sepsis. Running head: FLUID RESUSCITATION 9 Implications. The implications of this research reveal that there is no advantage to administering albumin versus saline in the reduction of mortality in sepsis patients. Based off of these conclusions, a sepsis patient c an be treated with either available intervention. Factors such as population, demographic, or available access have no determination in which product is administered. However, if economic burden is present, the use of crystalloids should be of first choice due to the cost of albumin- containing products. Running head: FLUID RESUSCITATION 10 References: Carlsen, S., & Perner, A. (2011). Initial Fluid Resuscitation of Patients with Septic Shock in the Intensive Care Unit. ACTA Anaesthesiologica Scandinavica, 394–400. doi:

10.1111/j.1399- 6576.2011.02399.x Delaney, A. P., Dan, A. P., McCaffrey, J. P., & Finfer, S. P. (2011). The Role of Albumin as a Resuscitation Fluid for Patients with Sepsis: A Systematic Review and Meta -Analysis.

Critical Care Medicine , 39(2), 386–391. doi: 10.1097/CCM.0b013e3181ffe217 Jiang, L., Jiang, S., Zhang, M., Zheng, Z., & Ma, Y. (2014). Albumin Versus Other Fluids for Fluid Resuscitation in Patients with Sepsis: A Meta -Analysis. PloS One , 1–21. doi:

0.1371/journal.pone.0114666 Liu, C., Lu, G., Wang , D., Lei, Y., Mao, Z., Hu, P., … Zhou, F. (2019). Balanced Crystalloids Versus Normal Saline for Fluid Resuscitation in Critically Ill Patients: A Systematic Review and Meta -Analysis with Trial Sequential Analysis. The American Journal of Emergency Medici ne, 37 (11), 2072–2078. doi: 10.1016/j.ajem.2019.02.045 Rochwerg, B. H., Alhazzani, W. J., Sindi, A. undefined, Heels -Ansdell , D. undefined, Thabane, L. undefined, Fox -Robichaud, A. undefined, … Annane, D. undefined. (2014). Fluid Resuscitation in Sepsis: A Systematic Review and Meta- Analysis. Annals of Internal Medicine, 1–11. doi: 10.7326/M14- 0178 Seccombe, A., McCluskey, L., Moorey, H., Lasserson, D., & Sapey, E. (2019). Assessing Fluid Resuscitation in Adults with Sepsis Who Are Not Mechanically Ventila ted: A Systematic Review of Diagnostic Test Accuracy Studies. Journal of General Internal Medicine , 1874–1883. doi: 10.1007/s11606- 019-05073- 9 Running head: FLUID RESUSCITATION 11 Appendix A Table 1. Summary Evidence Table Report Citation Design Method Sample Data Collection Data Analysis Validity and Reliability Carlsen & Perner (2011) To evaluate the current initial fluid resuscitation practice in patients with septic shock in the intensive care unit (ICU) and patient characteristics and outcome associated with fluid volume. Prospective cohort and observational study. Patients with septic shock admitted in six ICUs during a 3- month period. One -page case report form by the clinician of the patient in the specific ICU and entered into an Excel data sheet by a single research nurse. Although more severely shocked patients received higher volumes of crystalloids, colloids, and blood products, mortality did not differ between groups. Level I I LOE . Strong size of patient groups. Delaney, et al . (2011) To assess whether resuscitation with albumin -containing solutions, compared to other fluids, is associated with lower mortality in patients with sepsis. Prospective randomized clinical trials with quantitative data synthesis. Eight studies including patients with sepsis and nine studies of patients with sepsis as a subgroup.

Two reviewers independently extracted data onto data forms designed specifically for the study; data was checked for accuracy by a third reviewer. Evidence suggests albumin reduces mortality when used as a resuscitation fluid for patients with sepsis. Level I LOE.

Systematic review and meta- analysis with strong reliability. Jiang, et al . (2014) To evaluate whether the use of albumin -containing fluids for resuscitation in Fifteen randomized controlled trials. Patients with sepsis of any severity. Extraction of all relevant data was conducted by two authors independently. The present meta-analysis did not demonstrate significant Level I LOE. A meta -analysis with strong reliability. Running head: FLUID RESUSCITATION 12 patients with sepsis was associated with a decreased mortality rate. Methodological quality. advantage of using albumin - containing fluids for resuscitation in patients with sepsis of any severity. Liu, et al. (2019). To compare the efficacy and safety of balanced crystalloids with normal saline. Nine randomized controlled trials were identified. Methodological quality of included trials was assessed by two reviewers according to the Cochrane Risk of Bias Tool.

Critically ill patients over the age of 18 requiring fluid resuscitation. Two independent reviewers performed the data extraction using a standardized form. Among critically ill patients receiving crystalloid fluid therapy, the use of a balanced crystalloid compared with normal saline did not reduce the risk of mortality. Level I LO E. A systematic review and meta-analysis. Low risk of publication bias.

Limited sample size, >18 years. Rochwerg, et al. (2014). To examine the effect of different resuscitative fluids on mortality in patients with sepsis. 14 st udies (18,916 patients) with 15 direct comparisons. Adult patients with sepsis or septic shock. Two reviewers extracted data on study characteristics, methods, and outcomes. Risk of bias and quality of evidence were assessed. Among patients with sepsis, resuscitation with balanced crystalloids or albumin compared with other fluids seems to be associated with Level I LOE. A systematic review and network meta - analysis. Risk of bias.

Imprecise estimates. Running head: FLUID RESUSCITATION 13 reduced mortality. Seccombe, et al . (2019) To assess studies of diagnostic tests that identify the need for fluid resuscitation in adults with sepsis, as defined by the presence of fluid responsiveness. 594 patients within 14 studies.

Reported using PRISMA guidelines. Adults with sepsis without intensive care organ support, who would be appropriate for admission to an acute medical unit. Data was extracted using a piloted, standardized form, following translation of non-English language articles if required. Evidence to support fluid assessment in awake adults is lacking. Level I LOE. A systematic review with high reliability.

Median sample size and primarily single - centre.