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Date of event: jan2008 - feb2018.The device was reported to be a "7.5 fr pd catheter"; however, cook currently does not nor has previously ever manufactured a peritoneal dialysis catheter set in this size.Process of elimination was not able to associate this catheter with any of the other manufacturer devices used in this study.Additionally, the literature states "acute pd (apd) catheter (7.5, 8.5, and 9 fr; cook inc., in, usa)" were used, thus associating this device with cook and prompting this report.Clarification was requested but is unavailable.This report includes information known at this time.A follow-up report will be submitted should additional relevant information become available.
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It was reported to cook in a literature article titled "challenges of acute peritoneal dialysis in extremely-low-birth-weight infants: a retrospective cohort study" that peritoneal dialysis (pd) was performed on 12 extremely-low-birth-weight (elbw) infants with acute kidney injury (aki).Cook devices are believed to have been used on six of these patients.This report focuses on patient 12.Of the 12 selected patients, seven were male and five were female.The mean gestational ages and birth weights among the selected patients were reported to be (b)(6) weeks and (706.5 (± 220.5) grams.None of the infants had congenital defects of the genitourinary system.Using the neonatal kdigo aki classification, nine of the patients were classified as stage 3 while the remaining three were classified as stage 2.Two of the patients had aki due to multiple organ dysfunction syndrome (mods) after asphyxia in the delivery room.Two patients started treatment due to bilateral renal vein thrombosis.Ten of the patients were administered inotropes prior to their aki diagnosis.All patients were admitted to the user facility's nicu.Five had accompanying congenital heart disease and twin-to-twin transfusion.Specific patient details for these are unknown.The dialysis technique used was described to be the same for all patients.The catheters were inserted bedside as the patients did not have favorable conditions for transportation to the operating room.Under sterile conditions and using local anesthesia, 20-gauge guide needles were inserted at the counter-mcburney point ("the point over the left side of the abdomen that is one-third of the distance from the anterior superior iliac spine to the umbilicus") and were used to administer 3-5 ml of sterile saline.The insertion site of the catheter was checked via abdominal sonography prior to puncture.After the guide needle was inserted, contents of the syringe were assessed to "check for the presence of bowel injury".Following, an iv canula/pd catheter was inserted using a guide wire for peritoneal access.Four brands of catheters were used in this study, one being cook, prompting this report and the associated reports.Using simple x-ray, the location of the catheter tip was evaluated.The pf catheter tip "was placed in the lower portion of the pelvis".Pd was started immediately following catheter insertion.It was written that "dialysis solutions (hemosol or physioneal) were used at standard hydrous dextrose concentrations of 2.5 and 4.25% with osmolalities of 396 and 485mosm/l.To optimize ultrafiltration, the concentration of the dextrose in the dialysate was increased sequentially from 2.5 to 4.25% while monitoring the blood sugar level.Pd was started at a rate of 10 ml/kg, which was increased to 20¿ 30 ml/kg at 60¿120min/cycle continuing for 24 h; e.G.Starting with input time, 20-min dwell time, 10-min outflow, 30min in case of 60min)".The concentration of pd fluid was increased in four patients from 2.5% to 4.25% due to insufficient drainage, but was decreased in one patient from 4.25% to 2.5% due to hyperglycemia.The dwell time was set at a drainage period of 10min at this stage.Regarding changes in dwell time, it was written that "the initial pd cycle yielded an exchange inflow of 10 ml/kg for 10 min, a dwell time of 30 min, and a drain time of 20min.We adjusted the dwell time and dextrose concentration of the dialysis fluids according to ultrafiltration (uf)".All complications and patient outcomes were evaluated based on clinical manifestations as well as results of biochemistry/serology studies, simple x-rays, and echocardiography.Regarding overall results, it was written that "the average rate of reduction in the serum bun and cr levels during dialysis was 42.5% (range, 12¿64%) and 20.1% (range, 0¿70%), respectively.The sodium levels increased from 135.8 to 144.7mg/ml, and the potassium levels decreased from 6.8 to 5.0 mg/ml after 9.3 (±4.4) days".Patient 12 is the subject of this report.This patient was weaned from pd after their renal function improved with a negative net uf value.Their gestational age (weeks) was reported to be (b)(6).Their birth weight was 470 grams.Their cause of aki was reported to be sepsis with a 13-day onset.A 7.5 fr pd catheter was used on this patient with a dwell time of 70 minutes.The uf rate (ml/kg/h) was -0.12.Bun pre-/post-pd (mg/dl), cr pre-/post-pd (mg/dl), sodium pre-/post-pd (mg/dl), and potassium pre-/post-pd (mg/dl) values were reported to be 66/26, 2.92/.88, 151/142, and 9.7/6.Urine output pre-/post- pd (ml/kg/h) was 1.13/5.7.Complications included catheter obstruction.This patient was reported to have survived, completely recovering his renal function "as defined by normalization of the serum bun, cr, and electrolyte levels; thus, he did not require longterm rrt".Additional information regarding the patients, devices, and events, as well as clarification, was requested but is not available.All events associated with this literature are reported under patient identifiers: (b)(6).Noh, j., kim, c.Y., jung, e.Et al.Challenges of acute peritoneal dialysis in extremely-low-birth-weight infants: a retrospective cohort study.Bmc nephrol 21, 437 (2020).Https://doi.Org/10.1186/s12882-020-02092-1.
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