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CTRI Number  CTRI/2018/07/015127 [Registered on: 31/07/2018] Trial Registered Prospectively
Last Modified On: 20/08/2018
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Other (Specify) [nursing intervention]  
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Nursing guidelines on management of hypernatremia and diabetes insipidus. 
Scientific Title of Study   A randomized control trial to assess the effectiveness of nurse initiated guidelines on management of hypernatremia and diabetes DI among postoperative patients of sellar/ suprasellar tumour surgery. 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Hemlata 
Designation  M. Sc. Nursing 
Affiliation  Postgraduate Institute of medical Education and Research, chandigarh 
Address  NINE, PGIMER, Chandigarh Sec 12, Pin 160012
National institute of Nursing Education, PGIMER, Chandigarh Sec 12, Pin 160012
Chandigarh
CHANDIGARH
160012
India 
Phone  9736476477  
Fax    
Email  hemlatakoundal@ymail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Manju Dhandpani 
Designation  lecturer 
Affiliation  Postgraduate Institute of medical Education and Research, chandigarh 
Address  NINE, PGIMER, Chandigarh Sec 12, Pin 160012
National institute of Nursing Education, PGIMER, Chandigarh Sec 12, Pin 160012
Chandigarh
CHANDIGARH
160012
India 
Phone  9855151528  
Fax    
Email  manjuseban@gmail.com  
 
Details of Contact Person
Public Query  
Name  Hemlata 
Designation  M. Sc. Nursing 
Affiliation  Postgraduate Institute of medical Education and Research, chandigarh 
Address  NINE, PGIMER, Chandigarh Sec 12, Pin 160012
National institute of Nursing Education, PGIMER, Chandigarh Sec 12, Pin 160012
Chandigarh
CHANDIGARH
160012
India 
Phone  9736476477  
Fax    
Email  hemlatakoundal@ymail.com  
 
Source of Monetary or Material Support  
Hemlata 
 
Primary Sponsor  
Name  Hemlata 
Address  National institute of Nursing Education, PGIMER, Chandigarh Sec 12, Pin 160012 
Type of Sponsor  Other [Self] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Hemlata  Nehru Hospital, Postgraduate Institute of medical education and research, Chandigarh  neuro surgery ward, Nehru Hospital, Postgraduate Institute of medical education and research, Chandigarh
Chandigarh
CHANDIGARH 		 9736476477

hemlatakoundal@ymail.com 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 2  
Name of Committee  Approval Status 
Institutional Ethics Committee  Approved 
Institutional Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  Post operative patient with sellar and suprasellar tumour surgery,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  nurse initiated guidelines  nurse initiated guidelines for the management of diabetes inscipidus and hypernatremia 
Comparator Agent  Routine management  two group control and experimental group selected for the study, interventions for the experimental group are nurse initiated guidelines will providing like strict bedrest, nose, skin, mouth care, fluid and electolyte management, food avoided, sodium and protein restricted diet  
 
Inclusion Criteria  
Age From  11.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  1. All postoperative patients with sellar and suprasellar tumour admitted in neurosurgical units of Nehru Hospital, PGIMER, Chandigarh during July-September 2018.
2. Participant who will be willing to participate in the study.  
 
ExclusionCriteria 
Details  1. Patient having known case of:
-Diabetes insipidus
-Diseases causing fluid electrolyte imbalance like CRF/CKD/Renal disorder
2. The post operative patient with sellar and suprasellar tumour who are not willing to participate.
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Other 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Hypernatremia
1. Number of episodes
2. Severity
Diabetes insipidus
1. Number of episodes
2. Clinical manifestations of DI
 		 2 months
 
 
Secondary Outcome  
Outcome  TimePoints 
Secondary outcome variables
-Duration of hospital stay
-Number of readmission within a month.
Dehydration/ dry mouth,
Polydipsia,
Fatigue,
Irritability/ restlessness
Polyuria/ oliguria
Altered level of consciousness,
Tachycardia
 		 2 months 
 
Target Sample Size   Total Sample Size="50"
Sample Size from India="50" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   N/A 
Date of First Enrollment (India)   01/08/2018 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="0"
Months="2"
Days="15" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   not applicable 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Brief Summary   It is an randomized control trial will be done on the post operative patient of sellar and suprasellar tumours in the month of july- august 2018, In this trial 25 patient randomized for the control group and 25 patients randomized for the experimental group to see the effect of the nurse initiated guidelines on management of hypernatremia and diabetes insipidus. 
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