title: A fixed protocol for outpatient clinic routines in the care of patients with severe renal failure.
abstract: BACKGROUND
  The primary aim of this study was to assess whether a fixed protocol, using a specially trained team, for intermediate follow-up to fulfillment of guideline targets is non-inferior to conventional follow-up in the care of uraemic patients. A secondary aim was to investigate possible impact on patient outcome.
  
  
  METHODS
  The cohort comprised 424 patients from seven centers. Inclusion criteria were either serum creatinine exceeding 200 µmol/l or calculated clearance below 30 ml/min, representing CKD 4 or 5a. Six centers followed a standardized protocol (group 1). One center provided controls (group 2). The study design was prospective and interventional. The variables measured were blood hemoglobin, bicarbonate, calcium, phosphate, intact parathyroid hormone, albumin, renal function variables, blood pressure and RAAS blockade. The number of patients achieving the set goals was analyzed as a time trend to determine if the intervention resulted in an improvement.
  
  
  RESULTS
  At baseline, group 1 had significantly lower GFR and higher serum creatinine, calcium, phosphate, calcium × phosphate product and bicarbonate, lower mean arterial pressure (MAP), systolic blood pressures and less use of RAAS. During the intervention, group 1 improved in the direction of guidelines for blood hemoglobin, albumin, bicarbonate and MAP. Outcome of secondary endpoints gave a risk of death of 30% in both groups, while the risk of renal replacement therapy was higher in group 1.
  
  
  CONCLUSIONS
  However, the time to renal replacement therapy was significantly shorter in the intervention group, indicating that other variables than guideline achievements are important for the patient.
authors.affiliation: Department of Medicine and Nephrology, Kärnsjukhuset, Kärnsjukhuset, Skövde, Sweden. Henrik.Hadimeri@vgregion.se
authors.forename: Henrik
authors.initials: H
authors.lastname: Hadimeri
authors.forename: Carsten
authors.initials: C
authors.lastname: Frisenette-Fich
authors.forename: Sven-Ingemar
authors.initials: SI
authors.lastname: Deurell
authors.forename: Lars
authors.initials: L
authors.lastname: Svensson
authors.forename: Lena
authors.initials: L
authors.lastname: Carlsson-Bjering
authors.forename: Anders
authors.initials: A
authors.lastname: Fernström
authors.forename: Gabriel
authors.initials: G
authors.lastname: Almroth
authors.forename: Stefan
authors.initials: S
authors.lastname: Melander
authors.forename: Mattias
authors.initials: M
authors.lastname: Haarhaus
authors.forename: Per-Olof
authors.initials: PO
authors.lastname: Andersson
authors.forename: Agneta
authors.initials: A
authors.lastname: Cassel
authors.forename: Nils-Johan
authors.initials: NJ
authors.lastname: Mauritz
authors.forename: Agneta
authors.initials: A
authors.lastname: Ståhl-Nilsson
authors.forename: Jan
authors.initials: J
authors.lastname: Wilske
authors.forename: Kataryna
authors.initials: K
authors.lastname: Nordström
authors.forename: Pavel
authors.initials: P
authors.lastname: Oruda
authors.forename: Marie
authors.initials: M
authors.lastname: Eriksson
authors.forename: Annelie Inghilesi
authors.initials: AI
authors.lastname: Larsson
authors.forename: Bernd
authors.initials: B
authors.lastname: Stegmayr
mesh_terms: D000553:Ambulatory Care / Q000592:standards; D002985:Clinical Protocols; D005260:Female; D006454:Hemoglobins / Q000378:metabolism; D006801:Humans; D008297:Male; D017063:Outcome Assessment, Health Care; D011446:Prospective Studies; D051437:Renal Insufficiency / Q000097:blood / Q000628:therapy*; D012720:Severity of Illness Index
chemical_list: D006454:Hemoglobins