Inflammatory biomarkers, glycemic variability, hypoglycemia, and renal transplant outcomes: results of a randomized controlled trial.

BACKGROUND: We previously reported that compared to standard glycemic control [blood glucose (BG): 70-180 mg/dL], patients randomized to intensive glycemic control (BG: 70-110 mg/dL) were at increased risk of graft rejection in renal transplantation. However, the underlying mechanisms that associate the effect of intensive glycemic control with renal transplant outcomes have not been identified. METHODS: A secondary data analysis of 93 participants (n=44 intensive, n=49 control) was conducted using data from a previous randomized controlled clinical trial. We examined inflammatory biomarkers, glycemic variability, hypoglycemia, and hyperglycemia as potential contributing etiologies by assessing the effect of intensive glycemic control on these characteristics, and evaluate the association of these variables with graft rejection. RESULTS: Intensive glycemic control had no appreciable effect on highly sensitive C-reactive protein, interleukin (IL)-6, tumor necrosis factor alpha, IL-1ß, or IL-10 levels at all time points after transplantation. Moreover, neither inflammatory biomarkers nor increased glycemic variability were associated with graft rejection. However, intensive treatment increased the risk of hypoglycemia (BG <70 mg/dL, 84% vs. 25%, P<0.001). In sub-analysis, compared to non-rejecters, rejecters demonstrated higher rates of blood glucose below 70 mg/dL (90% vs. 49%, P=0.02). CONCLUSION: Inflammatory biomarkers and increased glycemic variability lack correlation with clinical outcomes in renal transplant, but importantly, increased perioperative hypoglycemic episodes (BG <70mg/dL) may be a salient etiology that contributed to the increased risk for acute allograft rejection related to intensive glycemic control. Further research is needed to confirm a causal association.

A randomized controlled trial to evaluate the effect of glycemic control on renal transplantation outcomes.

CONTEXT: Outcomes from intensive glycemic control postrenal transplant have not been studied. OBJECTIVE: Our objective was to observe the optimal management of hyperglycemia in patients with diabetes or impaired glucose tolerance receiving renal transplantation. DESIGN, SETTING, AND PATIENTS: We conducted a randomized controlled trial with patients undergoing renal transplantation randomized to either i.v. insulin therapy (intensive) or standard s.c. insulin therapy while the patients were admitted to the hospital. INTERVENTIONS: The study consisted of a 3-day postrenal transplant group treated with intensive i.v. insulin [blood glucose (BG) = 70-110 mg/dl] or a control group treated with s.c. insulin (BG = 70-180 mg/dl). MAIN OUTCOME MEASURE: The primary endpoint was delayed graft function (DGF). Secondary endpoints were glycemic control, graft survival, and acute rejection episodes. RESULTS: A total of 104 patients were screened and randomized to either the intensive or control condition; however, the intention-to-treat analysis set consisted of only the 93 participants (n = 44 intensive, n = 49 control) that underwent a renal transplant. DGF was present in 18% (eight of 44) of the intensive group and 24% (12 of 49) of the control group (P = 0.46). The occurrence of severe hypoglycemia (BG < 40 mg/dl) and severe hyperglycemia (BG > 350 mg/dl) were the primary safety outcome measures. There were nine participants with hypoglycemia identified, seven of which (78%) were in the intensive treatment group (P = 0.08). There were 30 instances of hyperglycemia with five participants (11%) in the intensive group and 12 participants (24%) in the control group having at least one hyperglycemic event (P = 0.10). For the 11 rejection episodes, nine were in the intensive treatment group (P = 0.013). CONCLUSIONS: The primary outcome measure of DGF was not statistically different for the two treatment groups. Regarding longer-term rejection and graft survival, the intensively treated participants were at higher risk for a rejection episode.

Using a webcast support service: experiences of in-person attendees of an implantable cardioverter defibrillator support group.

OBJECTIVE: Most patients with implantable cardioverter defibrillators (ICDs) adjust well to living with the device; however, some experience difficulties. Support groups assist in coping with the psychologic effects of living with an ICD. The study's aim was to examine acceptability of the in-person attendees of an ICD support group that was cast on the Internet. SAMPLE: A patient satisfaction survey describing the participants' experience was used as a measure of acceptability in this non-experimental, survey, pilot study. METHODS: The survey assessed reactions of the in-person participants with ICDs (N=46) to the introduction of webcasting and remote participation by other individuals with ICDs. Descriptive statistics were conducted. RESULTS: Participating in a webcasted support group was viewed as highly favorable, and responses indicated high satisfaction. CONCLUSION: Participants were satisfied with the webcast technology, enabling broader access to patients. Research is needed to assess the acceptability and satisfaction among remote participants and the group's effectiveness on clinical outcomes.

Disparities in preferences for receiving support and education among patients with implantable cardioverter defibrillators.

BACKGROUND: The implantable cardioverter-defibrillator (ICD) is the established treatment for patients with a history of or at risk for sudden cardiac arrest. Patients receiving an ICD are diverse, and little is known regarding their preferences for support and education postimplantation. The purpose of this study was to examine race, gender, and age preferences for receiving support and education (e.g., written, verbal). METHODS: Participants (N = 108, 75% Caucasian, 74% male, age 65 +/- 11 years) completed a research team-designed survey at a regularly scheduled clinic visit with the cardiac electrophysiologist at an academic medical center or offsite clinic. Descriptive statistics, Pearson chi(2), and independent t-tests were conducted. RESULTS: The study demonstrates important associations between race, gender, and age with patient preferences for support and education with regard to ICD care. African Americans preferred written materials (P = 0.006) and a phone call with the cardiologist (P =0.036). Women preferred an ICD support group (P = 0.023), a phone call with the device nurse (P = 0.027), and a professional counselor (P = 0.049). Women's choice to receive education from their cardiologist approached significance (P = 0.055). Patients < or =67 years of age preferred to receive support via an Internet chat room with other ICD patients (P =0.036), and to receive education via an Internet Web site (P = 0.022). CONCLUSIONS: Findings suggest methods of providing better care to ICD patients by offering them support and educational materials in their preferred modality. These data can aid in optimizing clinical care. Incorporating assessments of individual preferences into future clinical trial design is desirable.

Clinical trials update: sudden cardiac death prevention by implantable device therapy.

Sudden cardiac death represents an enormous public health problem in all developed countries of the world. In the United States, sudden cardiac death occurs in more than 400,000 people each year and is the leading cause of death. In sudden cardiac death, the heart abruptly and unexpectedly ceases to function (cardiac arrest), presumably because of an electrical disturbance. Individuals deemed high risk for sudden cardiac death may be treated with implantable defibrillators. This article highlights evidence from randomized, controlled trials of implantable device therapy used in prevention of sudden cardiac death.

Support group webcasting: a feasibility assessment.

Stress from chronic illness can be ameliorated by participation in support groups (SGs). Attending "gold standard" in-person, moderated SGs can be challenging. Taking care to address confidentiality concerns, we developed a web-based method for remote participants to "attend" in-person SGs. Authorized participants gain a realtime, audiovisual connection to the SG; on-site attendees discuss textual comments sent by remote participants to, and selected for discussion by, the group moderator. Feasibility studies with three SGs are encouraging.