Dataset Information

Substitution of perioperative albumin deficiency disorders (SuperAdd) in adults undergoing vascular, abdominal, trauma, or orthopedic surgery: protocol for a randomized controlled trial.

ABSTRACT: BACKGROUND:Hypalbuminemia is associated with numerous postoperative complications, so a perioperative albumin substitution is often considered. The objective of SuperAdd is to investigate whether substitution of human albumin, aiming to maintain a serum concentration >?30?g/l, can reduce postoperative complications in normovolemic surgical patients in comparison with standard care. METHODS/DESIGN:SuperAdd is a single-center, prospective, randomized, outcome-assessor blinded, patient blinded controlled trial. The primary outcome is the frequency of postoperative complications identified using the Postoperative Morbidity Survey graded ??2 according to the Clavien-Dindo Score. Adult patients at risk to develop hypalbuminemia, i.e., ASA III or IV or high-risk surgery, are recruited after written informed consent was obtained. The albumin concentration is assessed before the induction of anesthesia and every 3 h until admission to the postanesthesia care unit. If albumin concentrations drop below 30?g/l, patients are randomly allocated to the control or the treatment group. The study intervention is a goal-directed human albumin substitution aimed at a concentration >?30?g/l during surgery and postanesthesia care unit stay. The patients in the control group are treated according to standard clinical care. Postoperative visits are to be performed on days 1, 3, 5, 8, and 15, as well as by telephone 6?months after surgery. DISCUSSION:SuperAdd is the first clinical trial in a surgical population investigating the effect of a goal-directed albumin substitution aiming at a serum level >?30?g/l. The nonrestrictive selection of patients guarantees that the patients without albumin screening will most likely not develop hypalbuminemia, thus ensuring generalizability of the study results. TRIAL REGISTRATION:EudraCT 2016-001313-24. Registered on 5 September 2016. Clinical Trials NCT03167645. Registered on 18 October 2016 and has the Universal Trial Number (UTN) U1111-1181-2625.

SUBMITTER: Schaller SJ

PROVIDER: S-EPMC7433099 | biostudies-literature | 2020 Aug

REPOSITORIES: biostudies-literature

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Substitution of perioperative albumin deficiency disorders (SuperAdd) in adults undergoing vascular, abdominal, trauma, or orthopedic surgery: protocol for a randomized controlled trial.

Schaller Stefan J SJ Fuest Kristina K Ulm Bernhard B Schmid Sebastian S Bubb Catherina C von Eisenhart-Rothe Rüdiger R Friess Helmut H Kirchhoff Chlodwig C Stadlbauer Thomas T Luppa Peter P Blobner Manfred M Jungwirth Bettina B

Trials 20200818 1

<h4>Background</h4>Hypalbuminemia is associated with numerous postoperative complications, so a perioperative albumin substitution is often considered. The objective of SuperAdd is to investigate whether substitution of human albumin, aiming to maintain a serum concentration > 30 g/l, can reduce postoperative complications in normovolemic surgical patients in comparison with standard care.<h4>Methods/design</h4>SuperAdd is a single-center, prospective, randomized, outcome-assessor blinded, patie ...[more]

PMID: 32811539

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Project description:BACKGROUND:Evidence for benefit of endovascular aneurysm repair (EVAR) over open surgical repair for de novo infrarenal abdominal aortic aneurysms (AAAs) in younger patients remains conflicting because of heterogeneous study populations and small sample sizes. The objective of this study was to compare perioperative and short-term outcomes for EVAR and open surgery in younger patients using a large national disease and procedure-specific data set. METHODS:We identified patients 65 years of age or younger undergoing first-time elective EVAR or open AAA repair from the Vascular Quality Initiative (2003-2014). We excluded patients with pararenal or thoracoabdominal aneurysms, those medically unfit for open repair, and those undergoing EVAR for isolated iliac aneurysms. Clinical and procedural characteristics were balanced using inverse propensity of treatment weighting. A supplemental analysis extended the study to those younger than 70 years. RESULTS:We identified 2641 patients, 73% (n = 1928) EVAR and 27% (n = 713) open repair. The median age was 62 years (interquartile range, 59-64 years), and 13% were female. The median follow-up time was 401 days (interquartile range, 357-459 days). Unadjusted perioperative survival was 99.6% overall (open repair, 99.1%; EVAR, 99.8%; P < .001), with 97.4% 1-year survival overall (open repair, 97.3%; EVAR, 97.4%; P = .9). Unadjusted reintervention rates were five (open repair) and seven (EVAR) reinterventions per 100 person-years (P = .8). After propensity weighting, the absolute incidence of perioperative mortality was <1% in both groups (open repair, 0.9%, EVAR, 0.2%; P < .001), and complication rates were low. Propensity-weighted survival (hazard ratio, 0.88; 95% confidence interval, 0.56-1.38; P = .6) and reintervention rates (open repair, 6; EVAR, 8; reinterventions per 100 person-years; P = .8) did not differ between the two interventions. The analysis of those younger than 70 years showed similar results. CONCLUSIONS:In this study of younger patients undergoing repair of infrarenal AAA, 30-day morbidity and mortality for both open surgery and EVAR are low, and the absolute mortality difference is small. The prior published perioperative mortality and 1-year survival benefit of EVAR over open AAA repair is not observed in younger patients. Further studies of long-term durability are needed to guide decision-making for open repair vs EVAR in this population.

Project description:The dataset presented was collected via retrospective review from an orthopedic trauma database approved by the institutional review board at the author's institution from patients treated at any of the four hospitals serviced by the academic orthopedic surgery department. Femoral neck and intertrochanteric hip fracture patients from low energy mechanisms admitted between October 2014 and February 2020, were selected if they were age 55 or older and had recorded sex, body mass index (BMI), Charlson Comorbidity Index (CCI), American Society of Anaesthesiologists (ASA) physical status classification, Glasgow Coma Score, Abbreviated Injury Severity score for the chest, head and neck, and extremities, and ambulation status prior to injury. The resultant 1,590 subject dataset may be analysed via the supplied R statistical code to determine the frequency of equipoise in baseline and outcome variables from propensity matching via three matching schemes. The code implements three matching schemes including matching by (1) The Score for Trauma Triage in Geriatric and Middle-Aged (STTGMA) (2) CCI alone, or (3) a combination of sex, age, CCI and BMI. The code selects a subset of ten percent of hip fracture patients by a pseudorandom number generator (PRNG). The code matches the remaining patients 1:1 to the selected patients by propensity score generated by logistic regression of STTGMA, CCI, or a combination of sex, age, CCI and BMI using greedy nearest neighbor matching without replacement by the MatchIt package for R software. The code then compares matched cohorts by Chi-square, Fisher, or Mann-Whitney U test with significance level of 0.05 representing a 5% chance of significant differences due to random sampling of subjects. The supplied code repeats the random selection, matching and testing process 100,000 times for each matching method. The resultant code output is the frequency of significantly different demographic or outcome parameters among matched cohorts by matching method. This data and statistical code have reuse potential to explore alternative matching schemes. The supplied baseline variables should be robust enough to derive alternative risk scores for each patient which may be included as a matching variable for comparison. The authors also look forward to unexpected ways that this data may be used by readers.

Dataset Information

Substitution of perioperative albumin deficiency disorders (SuperAdd) in adults undergoing vascular, abdominal, trauma, or orthopedic surgery: protocol for a randomized controlled trial.

Publications

Substitution of perioperative albumin deficiency disorders (SuperAdd) in adults undergoing vascular, abdominal, trauma, or orthopedic surgery: protocol for a randomized controlled trial.

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